Bracketing approach for multiple strenght product EMA [Regulatives / Guidelines]

posted by dshah – India/ United Kingdom, 2021-07-17 11:44 (103 d 01:28 ago) – Posting: # 22474
Views: 386

Dear J!
If the dissolution is more than 85% in 15 min, then F2 would not be applicable. However, for multimedia dissolution for a BCS class II drug, there is a high possibility that in at least one media, the dissolution would be slower and thus F2 can be applied.
Regards,
Dshah

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