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

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Adopted guideline

Reference numberCPMP/ICH/2736/99
Published01/01/2003
Published01/08/2003
KeywordsStability, stability testing, stability data, chemical active substance, finished product, specification, storage conditions
DescriptionThis 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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