New FDA Guidance on Evaluation of Veterinary Stability Data
Posted 03 April 2012 | By
A new draft guidance for industry out of the US Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) aims to implement the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products' (VICH) GL51 quality measure.
The draft guidance, Statistical Evaluation Of Stability Data (VICH GL51), was released 4 April and deals with Step 4 of VICH's 9-step procedure.
"This draft guidance is intended to provide recommendations on how to use stability data generated in accordance with the principles detailed in the VICH guidance entitled, Stability Testing of New Veterinary Drug Substances and Medicinal Products, GL3(R) to propose a retest period or shelf life in a registration application," writes FDA.
FDA - Statistical Evaluation Of Stability Data (VICH GL51)
VICH - Homepage