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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.

Molecular Mechanisms for Species Differences in Organic Anion Transporter 1, OAT1: Implications for Renal Drug Toxicity.

Autor: Zou L; Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, California (L.Z., A.S., H.-C.C., S.W.Y., K.M.G.); Pharmacokinetics and Drug Metabolism, Amgen Inc., Cambridge, Massachusetts (A.G.); Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, Washington (B.P., L.W., J.D.U.); and Safety and ADME Translational Sciences, Drug Safety and Metabolism, IMED Biotech Unit, AstraZeneca, Cambridge, UK (S.H.S., K.S.F.)., Stecula A; Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, California (L.Z., A.S., H.-C.C., S.W.Y., K.M.G.); Pharmacokinetics and Drug Metabolism, Amgen Inc., Cambridge, Massachusetts (A.G.); Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, Washington (B.P., L.W., J.D.U.); and Safety and ADME Translational Sciences, Drug Safety and Metabolism, IMED Biotech Unit, AstraZeneca, Cambridge, UK (S.H.S., K.S.F.)., Gupta A; Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, California (L.Z., A.S., H.-C.C., S.W.Y., K.M.G.); Pharmacokinetics and Drug Metabolism, Amgen Inc., Cambridge, Massachusetts (A.G.); Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, Washington (B.P., L.W., J.D.U.); and Safety and ADME Translational Sciences, Drug Safety and Metabolism, IMED Biotech Unit, AstraZeneca, Cambridge, UK (S.H.S., K.S.F.)., Prasad B; Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, California (L.Z., A.S., H.-C.C., S.W.Y., K.M.G.); Pharmacokinetics and Drug Metabolism, Amgen Inc., Cambridge, Massachusetts (A.G.); Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, Washington (B.P., L.W., J.D.U.); and Safety and ADME Translational Sciences, Drug Safety and Metabolism, IMED Biotech Unit, AstraZeneca, Cambridge, UK (S.H.S., K.S.F.)., Chien HC; Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, California (L.Z., A.S., H.-C.C., S.W.Y., K.M.G.); Pharmacokinetics and Drug Metabolism, Amgen Inc., Cambridge, Massachusetts (A.G.); Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, Washington (B.P., L.W., J.D.U.); and Safety and ADME Translational Sciences, Drug Safety and Metabolism, IMED Biotech Unit, AstraZeneca, Cambridge, UK (S.H.S., K.S.F.)., Yee SW; Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, California (L.Z., A.S., H.-C.C., S.W.Y., K.M.G.); Pharmacokinetics and Drug Metabolism, Amgen Inc., Cambridge, Massachusetts (A.G.); Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, Washington (B.P., L.W., J.D.U.); and Safety and ADME Translational Sciences, Drug Safety and Metabolism, IMED Biotech Unit, AstraZeneca, Cambridge, UK (S.H.S., K.S.F.)., Wang L; Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, California (L.Z., A.S., H.-C.C., S.W.Y., K.M.G.); Pharmacokinetics and Drug Metabolism, Amgen Inc., Cambridge, Massachusetts (A.G.); Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, Washington (B.P., L.W., J.D.U.); and Safety and ADME Translational Sciences, Drug Safety and Metabolism, IMED Biotech Unit, AstraZeneca, Cambridge, UK (S.H.S., K.S.F.)., Unadkat JD; Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, California (L.Z., A.S., H.-C.C., S.W.Y., K.M.G.); Pharmacokinetics and Drug Metabolism, Amgen Inc., Cambridge, Massachusetts (A.G.); Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, Washington (B.P., L.W., J.D.U.); and Safety and ADME Translational Sciences, Drug Safety and Metabolism, IMED Biotech Unit, AstraZeneca, Cambridge, UK (S.H.S., K.S.F.)., Stahl SH; Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, California (L.Z., A.S., H.-C.C., S.W.Y., K.M.G.); Pharmacokinetics and Drug Metabolism, Amgen Inc., Cambridge, Massachusetts (A.G.); Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, Washington (B.P., L.W., J.D.U.); and Safety and ADME Translational Sciences, Drug Safety and Metabolism, IMED Biotech Unit, AstraZeneca, Cambridge, UK (S.H.S., K.S.F.)., Fenner KS; Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, California (L.Z., A.S., H.-C.C., S.W.Y., K.M.G.); Pharmacokinetics and Drug Metabolism, Amgen Inc., Cambridge, Massachusetts (A.G.); Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, Washington (B.P., L.W., J.D.U.); and Safety and ADME Translational Sciences, Drug Safety and Metabolism, IMED Biotech Unit, AstraZeneca, Cambridge, UK (S.H.S., K.S.F.)., Giacomini KM; Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, California (L.Z., A.S., H.-C.C., S.W.Y., K.M.G.); Pharmacokinetics and Drug Metabolism, Amgen Inc., Cambridge, Massachusetts (A.G.); Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, Washington (B.P., L.W., J.D.U.); and Safety and ADME Translational Sciences, Drug Safety and Metabolism, IMED Biotech Unit, AstraZeneca, Cambridge, UK (S.H.S., K.S.F.) kathy.giacomini@ucsf.edu.

Publikováno v: Molecular pharmacology [Mol Pharmacol] 2018 Jul; Vol. 94 (1), pp. 689-699. Date of Electronic Publication: 2018 May 02.

In vitro evaluation of hepatic transporter-mediated clinical drug-drug interactions: hepatocyte model optimization and retrospective investigation.

Autor: Bi YA; Department of Pharmacokinetics, Dynamics, and Metabolism, Pfizer Worldwide Research and Development, Pfizer, Inc., Mailstop 8220-2475, Groton, CT 06340, USA., Kimoto E, Sevidal S, Jones HM, Barton HA, Kempshall S, Whalen KM, Zhang H, Ji C, Fenner KS, El-Kattan AF, Lai Y

Publikováno v: Drug metabolism and disposition: the biological fate of chemicals [Drug Metab Dispos] 2012 Jun; Vol. 40 (6), pp. 1085-92. Date of Electronic Publication: 2012 Mar 01.

Mechanistic pharmacokinetic modeling for the prediction of transporter-mediated disposition in humans from sandwich culture human hepatocyte data.

Autor: Jones HM; Pfizer Worldwide R&D, Department of Pharmacokinetics, Dynamics and Metabolism, Sandwich, Kent, United Kingdom. hannah.jones@pfizer.com, Barton HA, Lai Y, Bi YA, Kimoto E, Kempshall S, Tate SC, El-Kattan A, Houston JB, Galetin A, Fenner KS

Publikováno v: Drug metabolism and disposition: the biological fate of chemicals [Drug Metab Dispos] 2012 May; Vol. 40 (5), pp. 1007-17. Date of Electronic Publication: 2012 Feb 16.