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!

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