Comparative BA study vs Biowaiver for BCS I [Dissolution / BCS / IVIVC]

posted by sameep – India, 2018-01-02 10:35 (2361 d 09:19 ago) – Posting: # 18132
Views: 4,595

Dear Helmut,

❝ Given that, for an ANDA I would say you have to re-invent the wheel.

That was the first impression. Thanks for confirming.

So, its better to conduct a comparative bioavailability study for BCS I, rather than biowaiver approach. :-)

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