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

  • Email
  • Help
Current effective version

Adopted guideline

Reference numberCPMP/ICH/2736/99
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.

Related content

How helpful is this page?

Average rating:

 Based on 49 ratings

Add your rating:

See all ratings
10 ratings
7 ratings
9 ratings
10 ratings
13 ratings

Tell us more