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

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.

Keywords: Stability, stability data, bracketing, matrixing

Current effective version

ICH: Q 1 D: Bracketing and matrixing designs for stability testing of drug substances and drug products - Step 5

AdoptedReference Number: CPMP/ICH/4104/00Legal effective date: 01/08/2002