VICH GL45 Bracketing and matrixing designs for stability testing of new veterinary drug substances and medicinal products - Scientific guideline

This document addresses recommendations on the application of bracketing and matrixing to stability studies conducted in accordance with principles outlined in the VICH GL3.

Keywords: Stability testing, bracketing, matrixing

Current effective version

VICH GL 45 quality: bracketing and matrixing designs for stability testing of new veterinary drug substances and medicinal products

Adopted Reference Number: EMA/CVMP/VICH/581467/2007 Legal effective date: 01/04/2010

Document history

VICH GL45: Bracketing and matrixing designs for stability testing of new veterinary drug substances and medicinal products - At step 4

Draft: consultation closed Reference Number: EMEA/CVMP/VICH/581467/2007-CON.