Interpreting Pilot study [Design Issues]

posted by rafimmc – 2007-07-12 15:14 (6928 d 17:39 ago) – Posting: # 885
Views: 5,439

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

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