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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.