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Registersample size for BA/BE studies [Regulatives / Guidelines]
Dear Dr.Muneesh,
I think no hard and fast rules for calculating sample size in particular method. Whatever method you are following it should be justifiable and you have to follow standard SOP/s. Now a day's many software available in market eg SAS.
As per FDA recommendation minimum N size to be 12 and the sample size will depend on variability of the study drug/s.
I hope my answer will help you.
I think no hard and fast rules for calculating sample size in particular method. Whatever method you are following it should be justifiable and you have to follow standard SOP/s. Now a day's many software available in market eg SAS.
As per FDA recommendation minimum N size to be 12 and the sample size will depend on variability of the study drug/s.
I hope my answer will help you.
—
Shankaranarayanan
Shankaranarayanan
Complete thread:
- sample size for BA/BE studies drmuneesh 2008-10-18 09:17 [Regulatives / Guidelines]
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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 studies drmuneesh 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 studiesshankar 2008-10-18 11:47
Ing. Helmut Schütz