Type-II Variation: Waive in-vivo study by providing in-vitro data? [Study As­sess­ment]

posted by Relaxation  – Germany, 2024-07-04 14:19 (13 d 13:09 ago) – Posting: # 24061
Views: 637

Hello everybody

❝ However all of the conditions required for a Class III waiver have to be met and this goes beyond simply showing dissolution similarity.

And as I happen to have the ICH M-9 just in front of me for other reasons, I cite chapter 3 first paragraph:
"A drug product is eligible for a BCS-based biowaiver ... drug product is the same dosage form and strength"

Best regards!

Complete thread:

UA Flag
 Admin contact
23,107 posts in 4,858 threads, 1,644 registered users;
68 visitors (0 registered, 68 guests [including 8 identified bots]).
Forum time: 03:29 CEST (Europe/Vienna)

All paid jobs absorb and degrade the mind.    Aristotle

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz