美国FDA 指导原则 体外药物相互作用研究-细胞色素P450酶和转运体介导的药物相互作用工业指南 英文原版.pdfVIP

In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) January 2020 Clinical Pharmacology In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002 Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 Email: druginfo@ /Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) January 2020 Clinical Pharmacology Contains Nonbinding Recommendations TABLE OF CONTENTS I. INTRODUCTION 1 II. BACKGROUND 2 III. EVALUATING METABOLISM-MEDIATED DRUG INTERACTIONS 2 A. Determining if the Investigational Drug is a Substrate of Metabolizing Enzymes 3 B. Determining if the Investigational Drug is an Inhibitor of Metabolizing Enzymes 3 C. Determining if the Investigational D