FDA发布ICH Q8(R2)药品研发指南（2009年11月终版，Docket No. FDA-2005-D-0154）
Q8(R2) Pharmaceutical Development
FDA发布ICH Q8(R2)《药品研发》终版指南，Docket编号FDA-2005-D-0154，该文件是对2006年5月发布的Q8母指南的第二次修订。2009年6月Q8母指南经修订增补附录，纳入质量源于设计（QbD）原则并形成Q8(R1)；Q8(R2)在此基础上更正了附录2第C节图2a和2b的图题。
GUIDANCE DOCUMENT
Q8(R2) Pharmaceutical Development November 2009
Final
- Docket Number:
- FDA-2005-D-0154
- Issued by:
-
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
This guidance is a revision of the ICH guidance Q8 Pharmaceutical Development (Q8 parent guidance) that published in May 2006. In June 2009, the Q8 parent guidance was revised to add an annex, which provides further clarification of the key concepts outlined in the May 2006 guidance and describes the principles of quality by design (QbD). The Q8(R1) document issued in June 2009 includes the Q8 parent guidance and the annex. This second revision, Q8(R2), provides corrected captions for figures 2a and 2b in Appendix 2, section C.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2005-D-0154.
来源：FDA Pharmaceutical Quality Documents · fda.gov