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

posted by Achievwin – US, 2019-12-03 17:06 (299 d 03:01 ago) – Posting: # 20909
Views: 1,090


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]

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