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