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RegisterBiowaiver for BCS Class II? [Dissolution / BCS / IVIVC]
posted by Helmut 
– Vienna, Austria, 2014-11-30 15:24 (3794 d 01:16 ago) – Posting: # 13957
Views: 6,635
Hi Srini,
Since the drug is BCS Class II and you have an additional excipient nobody will be able to give you such a “justification”. TGA’s BE-GL covers biowaivers for BCS Class I and – under certain conditions – Class III. Perform a biostudy.
❝ Justification require: There will not be any impact on Bioavailability/Bioequivalence with addition of the additional excipient which is not present in the registered formulation.
Since the drug is BCS Class II and you have an additional excipient nobody will be able to give you such a “justification”. TGA’s BE-GL covers biowaivers for BCS Class I and – under certain conditions – Class III. Perform a biostudy.
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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:
- Additional excipient justification srinivasuk 2014-11-30 08:53 [Dissolution / BCS / IVIVC]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Biowaiver for BCS Class II?Helmut 2014-11-30 14:24
- Additional excipient justification nobody 2014-11-30 20:44
- Additional excipient justification Dr_Dan 2014-12-02 09:34
- Additional excipient justification nobody 2014-12-02 10:38
- Additional excipient justification Dr_Dan 2014-12-02 09:34
Ing. Helmut Schütz