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GUIDANCE DOCUMENT

CVM GFI #75 (VICH GL5) Stability Testing-Photostability Testing of New Veterinary Drug Substances and Medicinal Products September 1999

Final
Docket Number:
FDA-1998-D-1165
Issued by:
Guidance Issuing Office
Center 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.


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-1998-D-1165.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002