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ICH Guidance on Veterinary Stability Data

04/04/2012

Federal Register Notice: FDA is making available, Draft Guidance for Industry on Statistical Evaluation of Stability Data, VICH GL51. It has been developed for veterinary use by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). It 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. It also covers stability studies using single- or multi-factor designs and full or reduced designs. To download this guidance, click here. To view this notice, click here.

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