Dissolution and bracketing - EMA [Regulatives / Guidelines]

posted by ping4santosh  – India, 2020-03-20 11:38 (252 d 20:33 ago) – Posting: # 21290
Views: 1,784

Hi Susanh,

We do face difficulties with the BCS IV drugs with low solubility.

If the reference product doesn't behave as the test product in Disso profile, you need to reformulate. What are your F values? Do you have separate F values with different strengths? If yes, pl share.

IMO, even if you follow the bracketing approach, you will have to prove the disso data for each strength you plan to register.

Could BE-studies been done on the highest and lowest strength and not on middle strengths in this case?

Yes, In Vivo BE studies can be done on the highest and lowest strengths.

Cheers, SKM

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