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

posted by AB661 – India, 2019-11-22 17:49  – Posting: # 20861
Views: 1,215

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

Edit: Category changed; see also this post #1[Helmut]

Complete thread:

 Admin contact
20,453 posts in 4,295 threads, 1,414 registered users;
online 20 (0 registered, 20 guests [including 10 identified bots]).
Forum time (Europe/Vienna): 00:36 CET

No one wants to learn from mistakes, but we cannot learn enough
from successes to go beyond the state of the art.    Henry Petroski

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz