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Guidance Issuing OfficeCenter for Veterinary Medicine
The VICH Harmonized Tripartite Guidance covering the Stability Testing of New Drug Substances and Products in the Veterinary Field (Parent Guidance) notes that light testing should be an integral part of stress testing. This document is an annex to the Parent Guidance and addresses the recommendations for photostability testing.
The intrinsic photostability characteristics of new drug substances and products should be evaluated to demonstrate that, as appropriate, light exposure does not result in unacceptable change.
The guidance primarily addresses the generation of photostability information for submission in Registration Applications for new molecular entities and associated drug products. The guidance does not cover the photostability of drugs after administration (i.e. under conditions of use) and those applications not covered by the Parent Guidance. Alternative approaches may be used if they are scientifically sound and justification is provided.
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:
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-1998-D-1165.