Research ArticleSpecial Section on Pediatric Drug Disposition and Pharmacokinetics
Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling
Nitin Mehrotra, Atul Bhattaram, Justin C. Earp, Jeffry Florian, Kevin Krudys, Jee Eun Lee, Joo Yeon Lee, Jiang Liu, Yeruk Mulugeta, Jingyu Yu, Ping Zhao and Vikram Sinha
Drug Metabolism and Disposition July 2016, 44 (7) 924-933; DOI: https://doi.org/10.1124/dmd.116.069559
Nitin Mehrotra
Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland
Atul Bhattaram
Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland
Justin C. Earp
Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland
Jeffry Florian
Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland
Kevin Krudys
Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland
Jee Eun Lee
Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland
Joo Yeon Lee
Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland
Jiang Liu
Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland
Yeruk Mulugeta
Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland
Jingyu Yu
Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland
Ping Zhao
Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland
Vikram Sinha
Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland
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In this issue
Research ArticleSpecial Section on Pediatric Drug Disposition and Pharmacokinetics
Application of Pharmacometrics in Pediatric Drug Development
Nitin Mehrotra, Atul Bhattaram, Justin C. Earp, Jeffry Florian, Kevin Krudys, Jee Eun Lee, Joo Yeon Lee, Jiang Liu, Yeruk Mulugeta, Jingyu Yu, Ping Zhao and Vikram Sinha
Drug Metabolism and Disposition July 1, 2016, 44 (7) 924-933; DOI: https://doi.org/10.1124/dmd.116.069559
Research ArticleSpecial Section on Pediatric Drug Disposition and Pharmacokinetics
Application of Pharmacometrics in Pediatric Drug Development
Nitin Mehrotra, Atul Bhattaram, Justin C. Earp, Jeffry Florian, Kevin Krudys, Jee Eun Lee, Joo Yeon Lee, Jiang Liu, Yeruk Mulugeta, Jingyu Yu, Ping Zhao and Vikram Sinha
Drug Metabolism and Disposition July 1, 2016, 44 (7) 924-933; DOI: https://doi.org/10.1124/dmd.116.069559
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