Bio-waiver of Sapropterin dihydrochloride powder for oral solution [Dissolution / BCS / IVIVC]

posted by AB661 – India, 2019-11-22 17:49  – Posting: # 20861
Views: 767

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]

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