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RegisterF ≥85%, no surfactants [Dissolution / BCS / IVIVC]
posted by Helmut 
– Vienna, Austria, 2014-05-09 12:51 (4434 d 07:29 ago) – Posting: # 12930
Views: 6,243
Hi Criss,
Did you read the guidelines on the topic? FDA: Class I, EMA & WHO: Class I and Class III under certain circumstances. Some Class IIa drugs (weak acids with high permeability) may be accepted on a case-by-case basis (see especially WHO’s TRS 937, Annex 7). Though deferasirox is a weak acid, dissolution media with surfactants are not acceptable and its fraction absorbed is not ≥85% → no chance.
❝ Could Deferasirox (BCS Class II) be qualified for biowaiver?
Did you read the guidelines on the topic? FDA: Class I, EMA & WHO: Class I and Class III under certain circumstances. Some Class IIa drugs (weak acids with high permeability) may be accepted on a case-by-case basis (see especially WHO’s TRS 937, Annex 7). Though deferasirox is a weak acid, dissolution media with surfactants are not acceptable and its fraction absorbed is not ≥85% → no chance.
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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:
- Deferasirox qualified for biowaiver? Criss 2014-05-08 23:17
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- F ≥85%, no surfactantsHelmut 2014-05-09 10:51
Ing. Helmut Schütz