ICH Q1C Stability testing: requirements for new dosage forms

  • Email
  • Help
Current effective version

Adopted guideline

Reference numberCPMP/ICH/280/95
KeywordsStability, dosage forms, line extension
DescriptionThis document addresses the recommendations on the data to be submitted regarding stability of new dosage forms by the owner of the original application, after the original submission for new active substances and medicinal products.

Related content

How helpful is this page?

Average rating:

 Based on 33 ratings

Add your rating:

See all ratings
7 ratings
6 ratings
6 ratings
6 ratings
8 ratings

Tell us more