ICH Q1A (R2) Stability testing of new drug substances and drug products - Scientific guideline

Table of contents

This document defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the ICH regions. It does not cover the information to be submitted for abbreviated or abridged applications, variations and clinical trial applications.

Keywords: Stability, stability testing, stability data, chemical active substance, finished product, specification, storage conditions


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