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RegisterPlease do your homework first [Dissolution / BCS / IVIVC]
posted by Helmut 
– Vienna, Austria, 2019-11-24 11:51 (2383 d 23:02 ago) – Posting: # 20864
Views: 6,134
Hi AB,
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.
❝ 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.
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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 firstHelmut 2019-11-24 10:51
- Bio-waiver of Sapropterin dihydrochloride powder for oral solution Achievwin 2019-12-03 17:06
Ing. Helmut Schütz