新药Ⅱ期和Ⅲ期临床试验药学申报资料的内容及格式要求(英语原文).pdf

Guidance for Industry INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) May 2003 CMC Guidance for Industry INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information Additional copies are available from: Office of Training and Communications Division of Drug Information (HFD-240) Center for Drug Evaluation and Research (CDER) 5600 Fishers Lane, Rockville, MD 20857 (Tel) 301-827-4573 Internet at /cder/guidance./index.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) May 2003 CMC Table of Contents I. INTRODUCTION 1 II. BACKGROUND 2 A. Current Requirements 2 B. General Principles 3 III. PHASE 2 STUDIES 6 A. Drug Substance 6 B. Drug Product 10 IV. PHASE 3 STUDIES 13 A. Drug Substance 13 B. Drug Product 18 V. PLACEBO 21 VI. LABELING 22 VII. ENVIRONMENTAL ASSESSMENTS 22 RESOURCES 23 Contains Nonbinding Recommendations