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Dear Mahesh and Kotu,
If I understand well the idea is only to test for futility. This is unusual in BE trials, but common practice in Phase III trials. The futility test should be described in the protocol submitted to the Ethics Committee.
What I think would not be acceptable to Agencies (at least in Europe) would be to dose all 50 subjects, collect all samples, analyse the samples of the first 25 subjects, conclude that bioequivalence is demonstrated, and not analyse the samples of the remaining 25 subjects.
❝ Interim analysis is not accepted by any regulatory.
❝ Only two stage design is allowed for the same. (Must be pre-defined in protocol)
If I understand well the idea is only to test for futility. This is unusual in BE trials, but common practice in Phase III trials. The futility test should be described in the protocol submitted to the Ethics Committee.
What I think would not be acceptable to Agencies (at least in Europe) would be to dose all 50 subjects, collect all samples, analyse the samples of the first 25 subjects, conclude that bioequivalence is demonstrated, and not analyse the samples of the remaining 25 subjects.
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Bioanalysis balakotu 2014-11-28 08:26 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bioanalysis Mahesh M 2014-11-28 08:54
- BioanalysisOhlbe 2014-11-28 14:15
- Stopping for futility Helmut 2014-11-28 14:21
- BioanalysisOhlbe 2014-11-28 14:15
- Bioanalysis priya 2014-11-28 13:41
- Bioanalysis Mahesh M 2014-11-28 08:54
Ing. Helmut Schütz