FDA发布Q1D新原料药和制剂稳定性试验括号法与矩阵法设计终版指南
Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
FDA发布终版指南Q1D，就括号法和矩阵法在稳定性试验中的应用提出建议，试验按ICH Q1A(R)所述原则开展。文件编号FDA-2001-D-0164，由CDER和CBER发布。FDA说明可随时在线或书面就任何指南提交意见，书面意见需标注该文件编号。
该终版指南针对按ICH Q1A(R)开展的新原料药和制剂稳定性试验，说明括号法与矩阵法设计的应用建议。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2001-D-0164
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
This guidance is intended to address recommendations on the application of bracketing and matrixing to stability studies conducted in accordance with principles outlined in the ICH guidance Q1A(R) Stability Testing of New Drug Substances and Products (the parent guidance).
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-2001-D-0164.
来源：FDA Pharmaceutical Quality Documents · fda.gov