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Guidance for Industry
行业指南
ANDAs: Stability Testing of Drug Substances and Products
ANDA:活性物质和药品的稳定性测试
DRAFT GUIDANCE
指南草案
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be
submitted within 90 days of publication in the Federal Register of the
notice announcing the availability of the draft guidance. Submit
electronic comments to http://www.regulations.gov. Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All
comments should be identified with the docket number listed in the notice
of availability that publishes in the Federal Register.
For questions regarding this draft document contact (CDER) Radhika
Rajagopalan 240-2768546.
U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
September 2012
OGD
Zhulikou431 作品, 丁香园论坛首发
Guidance for Industry
ANDAs: Stability Testing of Drug Substances and Products
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
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guid
ances/default.htm
U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
September 2012
OGD
Zhulikou431 作品, 丁香园论坛首发
TABLE OF CONTENTS目录
I. INTRODUCTION介绍
II. BACKGROUND背景
III. DISCUSSION 讨论
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行业指南
ANDA:活性物质和药品稳定性测试
上面这段是废话,不翻译。
注释 1:这份指南由仿制药办公室、FDA 的 CDER 的制药科学办公室起草。
I. 介绍
这份指南建议依据 FDCA 的 505(j)条款递交的 ANDA 申请和支持 ANDA 的 DMF 文
件,应该遵循 ICH 稳定性指南中的建议。
Zhulikou431 作品, 丁香园论坛首发
上面这段是废话,不翻译。
II.背景
在过去的这些年,仿制药办公室(OGD)已经收到大量关于 ANDA 相关稳定性数
据要求的申请。仿制药办公室目前发布的指南包括 1995 年的工业信件,表明仿
制药办公室将接受 ICH 推荐的关于稳定性研究的长期室温条件(就是 25±2℃,
60±5%RH)。尽管在那个时候,指南文本内容是足够使用的,但是这条建议对于
支持 ANDA 稳定性研究的基础,已经不再足够。
4. Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug
Substances and Products.
5. Q1E Evaluation of Stability Data
These will be referred to in the discussion that follows as ICH stability
guidances.
下面这些存在的ICH指南阐述了关于新活性物质和药品稳定性研究问题:
1.Q1A(R2)
2.Q1B
3.Q1C
4.Q1D
5.Q1E
在讨论中将提到要遵守ICH关于稳定性研究的指南。
III. DISCUSSION讨论
Although the ICH stability guidances were developed by ICH to provide
guidance on the information that should be provided in new drug
applications to ensure the stability of new drug substances and drug
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products, we believe the recommendations should be applied to ANDAs as
well.
尽管由ICH起草的ICH关于稳定性指南为新药申请需要提交信息提供指南,以确
保新活性物质和药品的稳定性,我们认为这些建议也应该适用于ANDA申请。
When following the ICH stability recommendations, the applicant should:
当采用ICH关于稳定性建议时,申请者应该:
1. Submit data from three pilot scale batches or two pilot batches and
one small scale batch. If the size of the pilot does not follow ICH
recommendations, the applicant should provide a justification.
递交的数据应该来自3批中试批次,或者2批中试批次和一个较小批次。如果中
试批次规模不符合ICH建议,申请者应该提供论证说明。
2. At the time of submission, provide 6 months of data that include
accelerated and long-term conditions. FDA recommends following ICH with
respect to utilization of intermediate conditions to support shelf-life.
在递交的时候,需要提交6个月数据,包括加速试验和长期试验数据。FDA建议
遵循ICH关于采用中间条件以支持有效期的做法。
3. Use multiple lots of drug substance as appropriate.
根据情况,使用多批次活性物质。
4. Manufacture and package the drug product using principles that are
representative of the commercial process.
药品的制造和包装的原则是可以代表商业化生产工艺。
5. Provide a fully packaged primary exhibit batch.
需要提供一个完整包装的原始展示批次。
6. Use three batches when using bracketing and matrixing designs under
ICH Q1D.
当根据ICH Q1D指南的括号法和矩阵法进行设计时,要使用3批次数据。
7. Provide statistical analysis of the data as appropriate, in accordance
with ICH Q1E, Appendix A.
根据情况,根据ICH Q1E指南附录A来提供数据统计分析。
If you choose to deviate from the above recommendations, you should
justify the approach you are taking.
如果你选择不采用上述建议,你应该提供论证来说明你采用的方法。
We update guidances periodically. To make sure you have the most recent
version of a guidance, check the FDA Drugs guidance Web page at http://www
fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/defa
ult htm.
注释2:我们定期更新指南,为了确保你获得最新版本指南,请核实FDA指南网
址:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Gui
dances/default htm.