ICH Q1E Evaluation of stability data - Scientific guideline

Table of contents

This document explains how to use stability data generated in accordance with the ICH guideline Q1A (R2) to propose a retest period or shelf life in a registration application. It covers stability studies using single- or multi-factor designs and full or reduced designs.

Keywords: Stability, stability data, evaluation, chemical active substance, finished product, herbal, evaluation, re-test period, shelf life


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