Issue Date: July 31, 2015
Issued by: Center for Veterinary Medicine
Topic(s): VICH
Status: Final
CVM GFI #198 (VICH GL45) Bracketing and Matrixing Designs For Stability Testing of New Veterinary Drug Substances and Medicinal Products
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.
Download the Guidance Document
