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RegisterBE biowaiver [Dissolution / BCS / IVIVC]
Could you please give your opinion on the following case for ANDA.
generic 100mg vs reference product 100mg f2 pass
generic 50mg vs reference product 50mg f2 pass
generic 25mg vs reference product 25mg f2 pass
generic 100mg vs reference product 100mg BE pass
Is this sufficient for a biowaiver for generic 50mg and 25mg
Or
Do we have to show
generic 100mg vs generic 50mg f2 pass
generic 100mg vs generic 25mg f2 pass
As well?
Reason is smaller tablets dissolution rates are faster and fail to pass f2 in most conditions.
generic 100mg vs reference product 100mg f2 pass
generic 50mg vs reference product 50mg f2 pass
generic 25mg vs reference product 25mg f2 pass
generic 100mg vs reference product 100mg BE pass
Is this sufficient for a biowaiver for generic 50mg and 25mg
Or
Do we have to show
generic 100mg vs generic 50mg f2 pass
generic 100mg vs generic 25mg f2 pass
As well?
Reason is smaller tablets dissolution rates are faster and fail to pass f2 in most conditions.
Complete thread:
- BE biowaiverrgamage 2012-02-13 03:53
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE biowaiver Dr_Dan 2012-02-13 11:35
Ing. Helmut Schütz