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Guidance on Stability Testing for New Veterinary Drugs

07/31/2015

Federal Register Notice: FDA is making available a guidance for industry entitled Bracketing and Matrixing Designs for Stability Testing of New Veterinary Drug Substances and Medicinal Products (VICH GL45). It has been developed for veterinary use by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products. This guidance is an annex to a VICH guidance GFI #73 entitled Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision) VICH GL. This VICH guidance document is intended to provide guidance on the application of reduced designs (i.e., bracketing and matrixing) for stability studies conducted in accordance with the principles outlined in VICH GL3. To download this guidance, click here. To view this notice, click here.

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