What are the recommendations for stability testing data of modified release dosage forms? 1.42K viewsOctober 10, 2022FDA 0 Sam Smith11.38K November 2, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted November 2, 2020 0 Comments Spread the lovePer ICH Q1A(R2) the applicant should provide data on three batches of all dosage forms including modified release dosage forms. ICH stability guidances do not distinguish among different dosage forms. Spread the love Login
