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Registersample size for BA/BE studies [Regulatives / Guidelines]
Dear EM
I mean to say that if I have done a pilot study, I will definitely have the intra-subject CV and %T/R ratio to calculate the appropriate sample size for the pivotal study. But if from the previous published literature, I get only intra-subject CV and not the %T/R ratio, in that case only should I assume T/R ratio of 0.95.
Best Regards
Dr Muneesh Garg
I mean to say that if I have done a pilot study, I will definitely have the intra-subject CV and %T/R ratio to calculate the appropriate sample size for the pivotal study. But if from the previous published literature, I get only intra-subject CV and not the %T/R ratio, in that case only should I assume T/R ratio of 0.95.
Best Regards
Dr Muneesh Garg
Complete thread:
- sample size for BA/BE studies drmuneesh 2008-10-18 09:17 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- sample size for BA/BE studies shankar 2008-10-18 11:47
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- sample size for BA/BE studies Helmut 2008-11-17 15:47
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- sample size for BA/BE studies ElMaestro 2008-11-18 08:49
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- sample size for BA/BE studies ElMaestro 2008-11-18 09:59
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- sample size for BA/BE studies drmuneesh 2008-11-20 08:30
- SAS and sample size d_labes 2008-11-19 11:33
- SAS and sample size drmuneesh 2008-11-20 08:31
- sample size for BA/BE studies ElMaestro 2008-11-19 10:48
- sample size for BA/BE studies drmuneesh 2008-11-19 10:14
- sample size for BA/BE studies drmuneesh 2008-11-18 10:27
- sample size for BA/BE studies ElMaestro 2008-11-18 09:59
- sample size for BA/BE studiesdrmuneesh 2008-11-18 09:31
- sample size for BA/BE studies ElMaestro 2008-11-18 08:49
- sample size for BA/BE studies drmuneesh 2008-11-18 07:44
- sample size for BA/BE studies ElMaestro 2008-11-17 14:32
- sample size for BA/BE studies Ohlbe 2008-10-18 13:32
- sample size for BA/BE studies drmuneesh 2008-10-18 12:18
- sample size for BA/BE studies shankar 2008-10-18 11:47
Ing. Helmut Schütz