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

posted by SMA – Europe, 2024-07-02 18:27 (15 d 09:17 ago) – Posting: # 24055
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Dear QA

❝ Is it possible to waive in-vivo study if we achieve similar in-vitro dissolution profile in multimedia between test products (BE batch vs new formulation) having different particle size?


BCS based biowaivers for class III products are possible according to the ICH M9 guideline which has already reached Step 5 in Europe (i.e. has been implemented).

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

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