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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.

Autor: 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.).

Publikováno v: 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.

Coproporphyrin I Can Serve as an Endogenous Biomarker for OATP1B1 Inhibition: Assessment Using a Glecaprevir/Pibrentasvir Clinical Study.

Autor: Kalluri HV; Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois, USA., Kikuchi R; Drug Metabolism and Pharmacokinetics, AbbVie Inc., North Chicago, Illinois, USA., Coppola S; Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois, USA., Schmidt J; Drug Metabolism and Pharmacokinetics, AbbVie Inc., North Chicago, Illinois, USA., Mohamed MF; Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois, USA., Bow DAJ; Drug Metabolism and Pharmacokinetics, AbbVie Inc., North Chicago, Illinois, USA., Salem AH; Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois, USA.; Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.

Publikováno v: Clinical and translational science [Clin Transl Sci] 2021 Jan; Vol. 14 (1), pp. 373-381. Date of Electronic Publication: 2020 Oct 24.

Discovery of 2-aminoisobutyric acid ethyl ester (AIBEE) phosphoramidate prodrugs for delivering nucleoside HCV NS5B polymerase inhibitors.

Autor: Randolph JT; Abbvie Incorporated, Global Pharmaceutical Research and Development, 1 North Waukegan Road, North Chicago, IL 60064, United States., Li T; Abbvie Incorporated, Global Pharmaceutical Research and Development, 1 North Waukegan Road, North Chicago, IL 60064, United States., Chris Krueger A; Abbvie Incorporated, Global Pharmaceutical Research and Development, 1 North Waukegan Road, North Chicago, IL 60064, United States., Heyman HR; Abbvie Incorporated, Global Pharmaceutical Research and Development, 1 North Waukegan Road, North Chicago, IL 60064, United States., Chen HJ; Abbvie Incorporated, Global Pharmaceutical Research and Development, 1 North Waukegan Road, North Chicago, IL 60064, United States., Bow DAJ; Abbvie Incorporated, Global Pharmaceutical Research and Development, 1 North Waukegan Road, North Chicago, IL 60064, United States., Van Handel C; Abbvie Incorporated, Global Pharmaceutical Research and Development, 1 North Waukegan Road, North Chicago, IL 60064, United States., Peterkin V; Abbvie Incorporated, Global Pharmaceutical Research and Development, 1 North Waukegan Road, North Chicago, IL 60064, United States., Carr RA; Abbvie Incorporated, Global Pharmaceutical Research and Development, 1 North Waukegan Road, North Chicago, IL 60064, United States., Stolarik D; Abbvie Incorporated, Global Pharmaceutical Research and Development, 1 North Waukegan Road, North Chicago, IL 60064, United States., Dekhtyar T; Abbvie Incorporated, Global Pharmaceutical Research and Development, 1 North Waukegan Road, North Chicago, IL 60064, United States., Irvin M; Abbvie Incorporated, Global Pharmaceutical Research and Development, 1 North Waukegan Road, North Chicago, IL 60064, United States., Krishnan P; Abbvie Incorporated, Global Pharmaceutical Research and Development, 1 North Waukegan Road, North Chicago, IL 60064, United States., Wagner R; Abbvie Incorporated, Global Pharmaceutical Research and Development, 1 North Waukegan Road, North Chicago, IL 60064, United States., DeGoey DA; Abbvie Incorporated, Global Pharmaceutical Research and Development, 1 North Waukegan Road, North Chicago, IL 60064, United States.

Publikováno v: Bioorganic & medicinal chemistry letters [Bioorg Med Chem Lett] 2020 Apr 01; Vol. 30 (7), pp. 126986. Date of Electronic Publication: 2020 Jan 25.

No Inhibition of MATE1/2K-Mediated Renal Creatinine Secretion Predicted With Ritonavir or Cobicistat.

Autor: Kikuchi R; Drug Metabolism and Pharmacokinetics-Translational Modeling, AbbVie Inc., North Chicago, Illinois 60064. Electronic address: ryota.kikuchi@abbvie.com., Chiou WJ; Drug Metabolism and Pharmacokinetics-Translational Modeling, AbbVie Inc., North Chicago, Illinois 60064., Kasai MA; Drug Metabolism and Pharmacokinetics-Translational Modeling, AbbVie Inc., North Chicago, Illinois 60064; University of Sao Paulo, Sao Paulo, Brazil., de Morais SM; Drug Metabolism and Pharmacokinetics-Translational Modeling, AbbVie Inc., North Chicago, Illinois 60064., Bow DAJ; Drug Metabolism and Pharmacokinetics-Translational Modeling, AbbVie Inc., North Chicago, Illinois 60064.

Publikováno v: Journal of pharmaceutical sciences [J Pharm Sci] 2019 Sep; Vol. 108 (9), pp. 3118-3123. Date of Electronic Publication: 2019 Apr 26.