Interpreting Pilot study [Design Issues]
Dear Sir,
We conducted a pilot study and got following results (T/R ratio and 90% Confidence Intervals).
Cmax 101.38%(78.76-130.49); Intrasubject CV 45.5%; Power 42.10%
AUC0-t 94.66% (76.05-117.84);Intrasubject CV 39.0%; Power 51.31%
AUC0-inf 95.16% (78.44-115.43);Intrasubject CV 34.1%; Power 60.50%
Sample size for pivotal study is found to be 64. Can we expect the pivotal study would clear the product or to recommend to reformulate the product?
Please suggest.
Thanks and Regards,
Rafimmc
We conducted a pilot study and got following results (T/R ratio and 90% Confidence Intervals).
Cmax 101.38%(78.76-130.49); Intrasubject CV 45.5%; Power 42.10%
AUC0-t 94.66% (76.05-117.84);Intrasubject CV 39.0%; Power 51.31%
AUC0-inf 95.16% (78.44-115.43);Intrasubject CV 34.1%; Power 60.50%
Sample size for pivotal study is found to be 64. Can we expect the pivotal study would clear the product or to recommend to reformulate the product?
Please suggest.
Thanks and Regards,
Rafimmc
Complete thread:
- Interpreting Pilot studyrafimmc 2007-07-12 13:14
- Cautious interpretation of HVD's pilot study Helmut 2007-07-12 15:41
- Cautious interpretation of HVD's pilot study rafimmc 2007-07-20 06:17
- MD to reduce variability Helmut 2007-07-22 13:42
- Cautious interpretation of HVD's pilot study rafimmc 2007-07-20 06:17
- Cautious interpretation of HVD's pilot study Helmut 2007-07-12 15:41
