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

posted by Achievwin – US, 2019-12-03 17:06 (504 d 03:40 ago) – Posting: # 20909
Views: 1,509


Innovator Biomarian was given Biowaiver based on the position that excipients (Mannitol) is same as oral tablets, additionally the powder for solution has a sucralose. See if this argument applies for you. Ref: SBA, Australian review points out that this is a a BCS III compound.

Best of luck and please post outcome of your experience in this forum.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]

Complete thread:

 Admin contact
21,419 posts in 4,475 threads, 1,510 registered users;
online 11 (0 registered, 11 guests [including 1 identified bots]).
Forum time: Tuesday 21:46 CEST (Europe/Vienna)

We have to remember that what we observe is not nature herself,
but nature exposed to our method of questioning.    Werner Heisenberg

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