Research ArticleArticle
Variability in P-Glycoprotein Inhibitory Potency (IC50) Using Various in Vitro Experimental Systems: Implications for Universal Digoxin Drug-Drug Interaction Risk Assessment Decision Criteria
Joe Bentz, Michael P. O’Connor, Dallas Bednarczyk, JoAnn Coleman, Caroline Lee, Johan Palm, Y. Anne Pak, Elke S. Perloff, Eric Reyner, Praveen Balimane, Marie Brännström, Xiaoyan Chu, Christoph Funk, Ailan Guo, Imad Hanna, Krisztina Herédi-Szabó, Kate Hillgren, Libin Li, Evelyn Hollnack-Pusch, Masoud Jamei, Xuena Lin, Andrew K. Mason, Sibylle Neuhoff, Aarti Patel, Lalitha Podila, Emile Plise, Ganesh Rajaraman, Laurent Salphati, Eric Sands, Mitchell E. Taub, Jan-Shiang Taur, Dietmar Weitz, Heleen M. Wortelboer, Cindy Q. Xia, Guangqing Xiao, Jocelyn Yabut, Tetsuo Yamagata, Lei Zhang and Harma Ellens
Drug Metabolism and Disposition July 2013, 41 (7) 1347-1366; DOI: https://doi.org/10.1124/dmd.112.050500
Joe Bentz
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Michael P. O’Connor
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Dallas Bednarczyk
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
JoAnn Coleman
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Caroline Lee
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Johan Palm
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Y. Anne Pak
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Elke S. Perloff
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Eric Reyner
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Praveen Balimane
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Marie Brännström
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Xiaoyan Chu
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Christoph Funk
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Ailan Guo
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Imad Hanna
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Krisztina Herédi-Szabó
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Kate Hillgren
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Libin Li
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Evelyn Hollnack-Pusch
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Masoud Jamei
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Xuena Lin
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Andrew K. Mason
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Sibylle Neuhoff
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Aarti Patel
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Lalitha Podila
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Emile Plise
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Ganesh Rajaraman
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Laurent Salphati
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Eric Sands
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Mitchell E. Taub
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Jan-Shiang Taur
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Dietmar Weitz
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Heleen M. Wortelboer
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Cindy Q. Xia
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Guangqing Xiao
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Jocelyn Yabut
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Tetsuo Yamagata
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Lei Zhang
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Harma Ellens
Drexel University, Department of Biology, Philadelphia, PA (J.B., M.P.O’C.); Optivia, Biotechnology, Menlo Park, CA (D.B.); GlaxoSmithKline Pharmaceuticals, Statistical Sciences (J.C.); Drug Metabolism and Pharmacokinetics, King of Prussia, PA (H.E.) and Ware, UK (A.P.); Pfizer, Inc., Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA (C.L., E.R.); AstraZeneca R&D Mölndal, Innovative Medicines, CVGI iMed DMPK, Mölndal, Sweden (J.P.); Eli Lilly and Company, Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, IN (Y.A.P., K.H.); BD Biosciences Discovery Labware, BD GentestSM Contract Research Services, Woburn, MA (E.S.P., A.K.M.); AstraZeneca R&D Mölndal, Innovative Medicines, R&I iMed DMPK (M.B.); Bristol-Myers Squibb, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ (P.B.); Merck & Co., Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Rahway, NJ (X.C., J.Y.); Non-Clinical Drug Safety, F. Hoffmann-La Roche, Basel, Switzerland (C.F., E.H.-P.); Non-Clinical Drug Safety, Hoffmann-La Roche, Nutley, NJ (A.G.); Novartis Institutes for BioMedical Research, East Hanover, NJ (I.H.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); Absorption Systems LP, Exton, PA (L.L.); Simcyp (a Certara company), John Street, Sheffield, UK (M.J., S.N.); Novartis Institute for BioMedical Research, Cambridge, MA (X.L.); Boehringer Ingelheim Pharmaceuticals, Inc., Drug Metabolism and Pharmacokinetics, Ridgefield, CT (L.P., M.E.T.); Genentech Inc., Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, CA (E.P., L.S.); CellzDirect-Life Technologies Ltd., Austin, TX (G.R.); Biogen Idec, Drug Metabolism and Pharmacokinetics, Cambridge, MA (E.S., G.X.); Eisai Inc., Andover, MA (J.T.); Sanofi-Aventis, R&D DSAR / Drug Disposition FF, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, MA (C.Q.X.); Merck Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany (T.Y.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (L.Z.)
Abstract
A P-glycoprotein (P-gp) IC50 working group was established with 23 participating pharmaceutical and contract research laboratories and one academic institution to assess interlaboratory variability in P-gp IC50 determinations. Each laboratory followed its in-house protocol to determine in vitro IC50 values for 16 inhibitors using four different test systems: human colon adenocarcinoma cells (Caco-2; eleven laboratories), Madin-Darby canine kidney cells transfected with MDR1 cDNA (MDCKII-MDR1; six laboratories), and Lilly Laboratories Cells—Porcine Kidney Nr. 1 cells transfected with MDR1 cDNA (LLC-PK1-MDR1; four laboratories), and membrane vesicles containing human P-glycoprotein (P-gp; five laboratories). For cell models, various equations to calculate remaining transport activity (e.g., efflux ratio, unidirectional flux, net-secretory-flux) were also evaluated. The difference in IC50 values for each of the inhibitors across all test systems and equations ranged from a minimum of 20- and 24-fold between lowest and highest IC50 values for sertraline and isradipine, to a maximum of 407- and 796-fold for telmisartan and verapamil, respectively. For telmisartan and verapamil, variability was greatly influenced by data from one laboratory in each case. Excluding these two data sets brings the range in IC50 values for telmisartan and verapamil down to 69- and 159-fold. The efflux ratio-based equation generally resulted in severalfold lower IC50 values compared with unidirectional or net-secretory-flux equations. Statistical analysis indicated that variability in IC50 values was mainly due to interlaboratory variability, rather than an implicit systematic difference between test systems. Potential reasons for variability are discussed and the simplest, most robust experimental design for P-gp IC50 determination proposed. The impact of these findings on drug-drug interaction risk assessment is discussed in the companion article (Ellens et al., 2013) and recommendations are provided.
Footnotes
- Received December 14, 2012.
- Accepted April 24, 2013.
↵1 Current affiliation: Novartis Institute for BioMedical Research, Cambridge, Massachusetts.
Work at Optivia was supported by Small Business Innovation Research Grants from the National Institutes of Health National Institute of General Medical Sciences [Grants R43GM086970-01, R43RR031474-01].
Disclaimer: The manuscript reflects the views of the authors and should not be construed to represent FDA’s views or policies. Lei Zhang has no conflict of interest to report.
↵
This article has supplemental material available at dmd.aspetjournals.org.
- U.S. Government work not protected by U.S. copyright
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In this issue
Research ArticleArticle
Interlaboratory Variability in P-gp IC50
Joe Bentz, Michael P. O’Connor, Dallas Bednarczyk, JoAnn Coleman, Caroline Lee, Johan Palm, Y. Anne Pak, Elke S. Perloff, Eric Reyner, Praveen Balimane, Marie Brännström, Xiaoyan Chu, Christoph Funk, Ailan Guo, Imad Hanna, Krisztina Herédi-Szabó, Kate Hillgren, Libin Li, Evelyn Hollnack-Pusch, Masoud Jamei, Xuena Lin, Andrew K. Mason, Sibylle Neuhoff, Aarti Patel, Lalitha Podila, Emile Plise, Ganesh Rajaraman, Laurent Salphati, Eric Sands, Mitchell E. Taub, Jan-Shiang Taur, Dietmar Weitz, Heleen M. Wortelboer, Cindy Q. Xia, Guangqing Xiao, Jocelyn Yabut, Tetsuo Yamagata, Lei Zhang and Harma Ellens
Drug Metabolism and Disposition July 1, 2013, 41 (7) 1347-1366; DOI: https://doi.org/10.1124/dmd.112.050500
Research ArticleArticle
Interlaboratory Variability in P-gp IC50
Joe Bentz, Michael P. O’Connor, Dallas Bednarczyk, JoAnn Coleman, Caroline Lee, Johan Palm, Y. Anne Pak, Elke S. Perloff, Eric Reyner, Praveen Balimane, Marie Brännström, Xiaoyan Chu, Christoph Funk, Ailan Guo, Imad Hanna, Krisztina Herédi-Szabó, Kate Hillgren, Libin Li, Evelyn Hollnack-Pusch, Masoud Jamei, Xuena Lin, Andrew K. Mason, Sibylle Neuhoff, Aarti Patel, Lalitha Podila, Emile Plise, Ganesh Rajaraman, Laurent Salphati, Eric Sands, Mitchell E. Taub, Jan-Shiang Taur, Dietmar Weitz, Heleen M. Wortelboer, Cindy Q. Xia, Guangqing Xiao, Jocelyn Yabut, Tetsuo Yamagata, Lei Zhang and Harma Ellens
Drug Metabolism and Disposition July 1, 2013, 41 (7) 1347-1366; DOI: https://doi.org/10.1124/dmd.112.050500
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