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Research ArticleArticle

Application of Receiver Operating Characteristic Analysis to Refine the Prediction of Potential Digoxin Drug Interactions

Harma Ellens, Shibing Deng, JoAnn Coleman, Joe Bentz, Mitchell E. Taub, Isabelle Ragueneau-Majlessi, Sophie P. Chung, Krisztina Herédi-Szabó, Sibylle Neuhoff, Johan Palm, Praveen Balimane, Lei Zhang, Masoud Jamei, Imad Hanna, Michael O’Connor, Dallas Bednarczyk, Malin Forsgard, Xiaoyan Chu, Christoph Funk, Ailan Guo, Kathleen M. Hillgren, LiBin Li, Anne Y. Pak, Elke S. Perloff, Ganesh Rajaraman, Laurent Salphati, Jan-Shiang Taur, Dietmar Weitz, Heleen M. Wortelboer, Cindy Q. Xia, Guangqing Xiao, Tetsuo Yamagata and Caroline A. Lee
Drug Metabolism and Disposition July 2013, 41 (7) 1367-1374; DOI: https://doi.org/10.1124/dmd.112.050542
Harma Ellens
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Shibing Deng
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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JoAnn Coleman
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Joe Bentz
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Mitchell E. Taub
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Isabelle Ragueneau-Majlessi
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Sophie P. Chung
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Krisztina Herédi-Szabó
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Sibylle Neuhoff
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Johan Palm
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Praveen Balimane
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Lei Zhang
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Masoud Jamei
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Imad Hanna
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Michael O’Connor
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Dallas Bednarczyk
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Malin Forsgard
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Xiaoyan Chu
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Christoph Funk
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Ailan Guo
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Kathleen M. Hillgren
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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LiBin Li
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Anne Y. Pak
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Elke S. Perloff
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Ganesh Rajaraman
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Laurent Salphati
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Jan-Shiang Taur
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Dietmar Weitz
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Heleen M. Wortelboer
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Cindy Q. Xia
Statistical Sciences (J.C.) and Drug Metabolism and Pharmacokinetics (H.E.), GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania; Clinical Research (S.D.) and Pharmacokinetics, Dynamics and Metabolism (C.A.L.), Pfizer Worldwide Research and Development–La Jolla Laboratories, San Diego, California; Department of Biology, Drexel University (J.B., M.O.), Philadelphia, Pennsylvania; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut (M.E.T.); Drug Interaction Database Program, Department of Pharmaceutics, University of Washington, Seattle, Washington (I.R.-M., S.P.C.); SOLVO Biotechnology, Budapest, Hungary (K.H.-S.); SimCyp (a Certara Company), Sheffield, United Kingdom (S.N., M.J.); Innovative Medicines, CVGI iMed DMPK (J.P.) and Global Drug Metabolism and Pharmacokinetics (M.F.), AstraZeneca Research & Development, Mölndal, Sweden; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (P.B.); Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland (L.Z.); Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey (I.H.); Optivia, Biotechnology, Menlo Park, California (D.B.); Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Rahway, New Jersey (X.C.); Non-Clinical Drug Safety, Hoffmann-La Roche, Basel, Switzerland (C.F.) and Nutley, New Jersey (A.G.); Investigative Drug Disposition, Lilly Research Laboratories, Indianapolis, Indiana (K.H., A.Y.P.); Absorption Systems LP, Exton, Pennsylvania (L.L.); BD Biosciences Discovery Labware, BD Gentest Contract Research Services, Woburn, Massachusetts (E.S.P.); CellzDirect-Life Technologies Ltd, Austin, Texas (G.R.); Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California (L.S.); Eisai Inc., Andover, Massachusetts (J-S.T.); DSAR/Drug Disposition FF, Sanofi-Aventis, Research & Development, Frankfurt am Main, Germany (D.W.); TNO, Zeist, The Netherlands (H.M.W.); Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts (C.Q.X.); Drug Metabolism and Pharmacokinetics, Biogen-Idec, Cambridge, Massachusetts (G.X.); and Institute of Drug Metabolism and Pharmacokinetics, Merck Serono, Grafing, Germany (T.Y.)
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Guangqing Xiao
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Tetsuo Yamagata
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Caroline A. Lee
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Abstract

In the 2012 Food and Drug Administration (FDA) draft guidance on drug-drug interactions (DDIs), a new molecular entity that inhibits P-glycoprotein (P-gp) may need a clinical DDI study with a P-gp substrate such as digoxin when the maximum concentration of inhibitor at steady state divided by IC50 ([I1]/IC50) is ≥0.1 or concentration of inhibitor based on highest approved dose dissolved in 250 ml divide by IC50 ([I2]/IC50) is ≥10. In this article, refined criteria are presented, determined by receiver operating characteristic analysis, using IC50 values generated by 23 laboratories. P-gp probe substrates were digoxin for polarized cell-lines and N-methyl quinidine or vinblastine for P-gp overexpressed vesicles. Inhibition of probe substrate transport was evaluated using 15 known P-gp inhibitors. Importantly, the criteria derived in this article take into account variability in IC50 values. Moreover, they are statistically derived based on the highest degree of accuracy in predicting true positive and true negative digoxin DDI results. The refined criteria of [I1]/IC50 ≥ 0.03 and [I2]/IC50 ≥ 45 and FDA criteria were applied to a test set of 101 in vitro-in vivo digoxin DDI pairs collated from the literature. The number of false negatives (none predicted but DDI observed) were similar, 10 and 12%, whereas the number of false positives (DDI predicted but not observed) substantially decreased from 51 to 40%, relative to the FDA criteria. On the basis of estimated overall variability in IC50 values, a theoretical 95% confidence interval calculation was developed for single laboratory IC50 values, translating into a range of [I1]/IC50 and [I2]/IC50 values. The extent by which this range falls above the criteria is a measure of risk associated with the decision, attributable to variability in IC50 values.

Footnotes

    • Received December 14, 2012.
    • Accepted April 19, 2013.
  • ↵1 Current affiliation: Novartis Institute for BioMedical Research, Cambridge, Massachusetts. 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.

  • 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 and R43RR031474-01].

  • dx.doi.org/10.1124/dmd.112.050542.

  • ↵Embedded ImageThis article has supplemental material available at dmd.aspetjournals.org.

  • U.S. Government work not protected by U.S. copyright
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Drug Metabolism and Disposition: 41 (7)
Drug Metabolism and Disposition
Vol. 41, Issue 7
1 Jul 2013
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Application of Receiver Operating Characteristic Analysis to Refine the Prediction of Potential Digoxin Drug Interactions
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Research ArticleArticle

ROC Refined Digoxin DDI Criteria

Harma Ellens, Shibing Deng, JoAnn Coleman, Joe Bentz, Mitchell E. Taub, Isabelle Ragueneau-Majlessi, Sophie P. Chung, Krisztina Herédi-Szabó, Sibylle Neuhoff, Johan Palm, Praveen Balimane, Lei Zhang, Masoud Jamei, Imad Hanna, Michael O’Connor, Dallas Bednarczyk, Malin Forsgard, Xiaoyan Chu, Christoph Funk, Ailan Guo, Kathleen M. Hillgren, LiBin Li, Anne Y. Pak, Elke S. Perloff, Ganesh Rajaraman, Laurent Salphati, Jan-Shiang Taur, Dietmar Weitz, Heleen M. Wortelboer, Cindy Q. Xia, Guangqing Xiao, Tetsuo Yamagata and Caroline A. Lee
Drug Metabolism and Disposition July 1, 2013, 41 (7) 1367-1374; DOI: https://doi.org/10.1124/dmd.112.050542

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ROC Refined Digoxin DDI Criteria

Harma Ellens, Shibing Deng, JoAnn Coleman, Joe Bentz, Mitchell E. Taub, Isabelle Ragueneau-Majlessi, Sophie P. Chung, Krisztina Herédi-Szabó, Sibylle Neuhoff, Johan Palm, Praveen Balimane, Lei Zhang, Masoud Jamei, Imad Hanna, Michael O’Connor, Dallas Bednarczyk, Malin Forsgard, Xiaoyan Chu, Christoph Funk, Ailan Guo, Kathleen M. Hillgren, LiBin Li, Anne Y. Pak, Elke S. Perloff, Ganesh Rajaraman, Laurent Salphati, Jan-Shiang Taur, Dietmar Weitz, Heleen M. Wortelboer, Cindy Q. Xia, Guangqing Xiao, Tetsuo Yamagata and Caroline A. Lee
Drug Metabolism and Disposition July 1, 2013, 41 (7) 1367-1374; DOI: https://doi.org/10.1124/dmd.112.050542
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