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

Table of contents

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


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