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

Current effective version

PDF iconAdopted guideline

Reference number CPMP/ICH/2736/99
Published 01/01/2003
Published 01/08/2003
Keywords Stability, stability testing, stability data, chemical active substance, finished product, specification, storage conditions
Description 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.

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