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RegisterPilot Study always needed? [Power / Sample Size]
Hi,
Before conducting Pivotal study do you always require to conduct a pilot study of the same generic drug for calculation of intrasubject variability (of pilot study and then using this varibility for calculation of sample size for pivotal study).
If the literature/pilot study is not available/conducted and a pivotal study is to be conducted then which/what intrasubject variability do you consider for those generic drugs.
With Regards,
Venu.
Before conducting Pivotal study do you always require to conduct a pilot study of the same generic drug for calculation of intrasubject variability (of pilot study and then using this varibility for calculation of sample size for pivotal study).
If the literature/pilot study is not available/conducted and a pivotal study is to be conducted then which/what intrasubject variability do you consider for those generic drugs.
With Regards,
Venu.
—
Best Regards,
Ms. Vandana Panchal
Biostatistician
Mumbai
India
Best Regards,
Ms. Vandana Panchal
Biostatistician
Mumbai
India
Complete thread:
- Pilot Study always needed?venu 2006-10-30 11:33
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Pilot Study not always needed! Helmut 2006-10-30 13:09
- Expected difference in formulations Ahmed meeran 2006-11-01 12:37
- Expected difference in formulations Helmut 2006-11-01 14:56
- Pilot Study not always needed! youri 2006-12-12 17:12
- CV Estimation from CI... Helmut 2006-12-12 17:47
- Expected difference in formulations Ahmed meeran 2006-11-01 12:37
- Pilot Study not always needed! Helmut 2006-10-30 13:09
Ing. Helmut Schütz