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GUIDANCE DOCUMENT

Q1B Photostability Testing of New Drug Substances and Products March 1996

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Issued by:
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.

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