美国FDA 指导原则 胃液pH依赖性药物与降酸剂相互作用的评价研究设计、数据分析和临床意义工业指南 英文原版.pdfVIP

Evaluation of Gastric pH- Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) March 2023 Clinical Pharmacology Evaluation of Gastric pH- Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications 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 10001 New 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/guidance-compliance-regulatory-information/guidances-drugs U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) March 2023 Clinical Pharmacology Contains Nonbinding Recommendations TABLE OF CONTENTS I. INTRODUCTION 1 II. WHEN CLINICAL DDI STUDIES WITH ARAS SHOULD BE CONDUCTED 2 A. Immediate-Release Products of Weak-Base Drugs2 B. Immediate-Release Products of Weak-Acid Drugs5 C. Modified-Release Products 5 III. DESIGN AND CONDUCT OF CLINICAL DDI STUDIES 5 IV. ALTERNATIVE APPROACHES