biowaiver for higher strength [Regulatives / Guidelines]

posted by jag009  – NJ, 2022-01-24 08:48 (429 d 06:02 ago) – Posting: # 22747
Views: 1,763

Hi folks,

A weird question about an immediate release product.
If I have
1) A BE study showing BE between a test and a reference at lower strength
2) A higher strength test product that is formulation proportional to the lower strength test product but the strengths are not interchangeable (meaning for example the lower strength product is 160 mg and the higher strength product is 500 mg).
3) Dissolution test lower vs higher strengths f2> 50.
4) I have efficacy and safety data for a reference product. Same molecule, immediate release and same strength as the highest strength test product.

Based on the above, can I file a biowaiver for the higher strength test product so I don't have to run a PK BE study?

This is an NDA.


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