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GUIDANCE DOCUMENT

CVM GFI #198 (VICH GL45) Bracketing and Matrixing Designs For Stability Testing of New Veterinary Drug Substances and Medicinal Products July 2015

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2009-D-0309
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

VICH GL3(R), “Stability Testing of New Veterinary Drug Substances and Medicinal Products,” notes that the use of matrixing and bracketing can be applied, if justified, to the testing of new veterinary drug substances and medicinal products, but provides no further guidance on the subject.

This document provides guidance on bracketing and matrixing study designs. Specific principles are defined in this guidance for situations in which bracketing or matrixing can be applied. Sample designs are provided for illustrative purposes, and should not be considered the only, or the most appropriate, designs in all cases.

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All written comments should be identified with this document's docket number: FDA-2009-D-0309.

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