美国FDA 指导原则 提交简明新药申请的生物等效性汇总数据 英文原版.pdfVIP

Guidance for Industry Submission of Summary Bioequivalence Data for ANDAs U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) May 2011 Generics Guidance for Industry Submission of Summary Bioequivalence Data for ANDAs Additional copies are available from: Office of Communications Division of Drug Information, WO51, Room 2201 Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave. Silver Spring, MD 20993-0002 Phone: 301-796-3400; Fax: 301-847-8714 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) May 2011 Generics Contains Nonbinding Recommendations TABLE OF CONTENTS I. INTRODUCTION 1 II. BACKGROUND 2 III. SUBMISSION OF ALL BIOEQUIVALENCE STUDIES 2 A. What Types of ANDA Submissions Must Include All BE Studies? 3 B. What Format Should Be Used for a Summary Report? 3 IV. SAME DRUG PRODUCT FORMULATION 3 A. Immediate-Release Drug Products4 1. Immediate-Re