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RegisterBio-waiver of Sapropterin dihydrochloride powder for oral solution [Dissolution / BCS / IVIVC]
Dear All,
We are developing Sapropterin dihydrochloride powder for oral solution,
We are going to file BCS based Bio-waiver approach using solubility, dissolution & composition similarity.
But for permeability study there is no literature support for human absolute bioavailability study or in-vitro permeability study of Sapropterin dihydrochloride. Whether USFDA accept our proposal without permeability study data ?
With regards
AB
Edit: Category changed; see also this post #1. [Helmut]
We are developing Sapropterin dihydrochloride powder for oral solution,
We are going to file BCS based Bio-waiver approach using solubility, dissolution & composition similarity.
But for permeability study there is no literature support for human absolute bioavailability study or in-vitro permeability study of Sapropterin dihydrochloride. Whether USFDA accept our proposal without permeability study data ?
With regards
AB
Edit: Category changed; see also this post #1. [Helmut]
Complete thread:
- Bio-waiver of Sapropterin dihydrochloride powder for oral solutionAB661 2019-11-22 17:49
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Please do your homework first Helmut 2019-11-24 10:51
- Bio-waiver of Sapropterin dihydrochloride powder for oral solution Achievwin 2019-12-03 17:06
Ing. Helmut Schütz