ICH Q1D Bracketing and matrixing designs for stability testing of drug substances and drug products

Current effective version

PDF iconAdopted guideline

Reference number CPMP/ICH/4104/00
Published 01/02/2002
Effective from 01/08/2002
Keywords Stability, stability data, bracketing, matrixing
Description This document provides guidance on bracketing and matrixing study designs in accordance with ICH guideline Q1A(R2). It defines specific principles for situations in which bracketing or matrixing can be applied. Sample designs are provided for illustrative purposes.


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