FDA发布Q1B新原料药和制剂光稳定性试验指南草案并征求意见
Q1B Photostability Testing of New Drug Substances and Products
FDA发布Q1B新原料药和制剂光稳定性试验指南草案，并说明该草案不用于实施、所载建议不具约束力。文件由FDA药品审评与研究中心（CDER）和生物制品审评与研究中心（CBER）发布，是ICH新原料药和制剂稳定性试验母指南的附录，针对光稳定性试验提出建议。意见可通过案卷编号FDA-2013-S-0610提交。
GUIDANCE DOCUMENT
Draft
Not for implementation. Contains non-binding recommendations.
- Issued by:
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Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
The ICH Harmonized Tripartite Guideline on Stability Testing of New Drug Substances and Products (hereafter referred to as the parent guideline) notes that light testing should be an integral part of stress testing. This document is an annex to the parent guideline and addresses the recommendations for photostability testing.
Submit Comments
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
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 comments should be identified with the title of the guidance.
来源：FDA Pharmaceutical Quality Documents · fda.gov