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RegisterBio-waiver of Sapropterin dihydrochloride powder for oral solution [Dissolution / BCS / IVIVC]
Hi:
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.
Achievwin
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]
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.
Achievwin
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:
- Bio-waiver of Sapropterin dihydrochloride powder for oral solution AB661 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 solutionAchievwin 2019-12-03 17:06
Ing. Helmut Schütz