ICH Q1C Stability testing: requirements for new dosage forms

Current effective version

PDF iconAdopted 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 useful was this page?

Add your rating