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

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Current effective version

Adopted guideline

Reference numberCPMP/ICH/4104/00
Published01/02/2002
Effective from01/08/2002
KeywordsStability, stability data, bracketing, matrixing
DescriptionThis 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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