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AB661 ☆ India, 2019-11-22 18:49 (1607 d 03:55 ago) Posting: # 20861 Views: 4,523 |
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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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Helmut ★★★   Vienna, Austria, 2019-11-24 11:51 (1605 d 10:53 ago) @ AB661 Posting: # 20864 Views: 3,269 |
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Hi AB, ❝ Whether USFDA accept our proposal without permeability study data ? No way – and for good reasons. Though the drug is highly soluble, you don’t know whether it is in class 1 or 3 (Guidance Sections III.B. and VII.B.). Biowaivers for class 3 drugs are acceptable only if fulfilling certain conditions. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Achievwin ★ US, 2019-12-03 18:06 (1596 d 04:38 ago) @ AB661 Posting: # 20909 Views: 3,317 |
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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] |
Ing. Helmut Schütz