Survey of Pharmaceutical Industry's Best Practices around In Vitro Transporter Assessment and Implications for Drug Development: Considerations from the International Consortium for Innovation and Quality for Pharmaceutical Development Transporter Working Group.

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Title: Survey of Pharmaceutical Industry's Best Practices around In Vitro Transporter Assessment and Implications for Drug Development: Considerations from the International Consortium for Innovation and Quality for Pharmaceutical Development Transporter Working Group.
Authors: Rollison HE; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Mitra P; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.) pallabi.mitra@boehringer-ingelheim.com., Chanteux H; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Fang Z; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Liang X; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Park SH; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Costales C; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Hanna I; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Thakkar N; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Vergis JM; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Bow DAJ; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Hillgren KM; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Brumm J; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Chu X; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Hop CECA; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Lai Y; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Li CY; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Mahar KM; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Salphati L; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Sane R; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Shen H; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Taskar K; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Taub M; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Tohyama K; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Xu C; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.)., Fenner KS; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (H.E.R., K.S.F.); Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut (P.M., M.T.); Quantitative Clinical Pharmacology, Development Sciences, UCB Biopharma SRL, Braine-L'Alleud, Belgium (H.C.); NCE Drug Metabolism and Pharmacokinetics, the healthcare business of Merck KGaA, Darmstadt, Germany (Z.F.); Drug Metabolism, Gilead Sciences, Inc. Foster City, California (X.L., Y.L.); Preclinical Sciences and Translational Safety, Janssen R&D LLC, Spring House, Pennsylvania (S.H.P.); Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Worldwide R&D, Pfizer Inc, Groton, Connecticut (C.C.); Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey (I.H.); Clinical Pharmacology Modelling and Simulations, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania (N.T., K.M.M.); IQ Secretariat, Faegre Drinker Biddle & Reath, LLP., Washington DC (J.M.V.); Quantitative, Translational and ADME Sciences, AbbVie Inc., North Chicago, Illinois (D.A.J.B.); Investigative Drug Disposition, Lilly Research Laboratories, Eli Lilly Inc, Indianapolis, Indiana (K.M.H.); Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California (J.B.); ADME and Discovery Toxicity, Merck & Co., Inc., Rahway, New Jersey (X.C.); Departments of Drug Metabolism and Pharmacokinetics (C.E.C.A.H., L.S.) and Clinical Pharmacology (R.S.), Genentech, Inc., South San Francisco, California; Department of Pharmacokinetics and Drug Metabolism, Amgen Inc. South San Francisco, California (C.Y.L.); Department of Drug Metabolism and Pharmacokinetics, Bristol Myers Squibb Research and Development, Princeton, New Jersey (H.S.); DMPK Modeling, IVIVT, Research, GSK, Stevenage, United Kingdom (Ku.T.); Takeda Pharmaceutical Company Limited, Fujisawa, Japan (Ki.T.); and Pharmacokinetics, Dynamics, and Metabolism, Translational Medicine and Early Development, Sanofi US, Bridgewater, NJ (C.X.).
Source: Drug metabolism and disposition: the biological fate of chemicals [Drug Metab Dispos] 2024 Jun 17; Vol. 52 (7), pp. 582-596. Date of Electronic Publication: 2024 Jun 17.
Publication Type: Journal Article
Journal Info: Publisher: American Society for Pharmacology and Experimental Therapeutics, etc.] Country of Publication: Netherlands NLM ID: 9421550 Publication Model: Electronic Cited Medium: Internet ISSN: 1521-009X (Electronic) Linking ISSN: 00909556 NLM ISO Abbreviation: Drug Metab Dispos Subsets: MEDLINE
Database: MEDLINE Ultimate
Description
ISSN:1521-009X
DOI:10.1124/dmd.123.001587