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201405 FDA指南：ANDA：原料药和制剂稳定性试验问答

Guidance for Industry 行业指南

ANDAs: Stability Testing of Drug Substances and Products

Questions and Answers

ANDA：原料药和制剂稳定性试验问答

Final GUIDANCE 最终稿指南

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

May 2014 Generics

Guidance for Industry

ANDAs: Stability Testing of Drug Substances and Products

Questions and Answers

ANDA：原料药和制剂稳定性试验问答 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

Phone: 301-796-3400; Fax: 301-847-8714

druginfo@fda.hhs.gov

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

May 2014 Generics

TABLE OF CONTENTS 目录

I. INTRODUCTION介绍

II. QUESTIONS AND ANSWERS提问和回答 A. General一般问题

B. Drug Master File药物主文件.

C. Drug Product Manufacturing and Packaging药品生产和包装

D. Amendments to Pending ANDA Application未批准ANDA申请的增补 E. Stability Studies稳定性试验.