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RegisterFailed Pilot Bio [Power / Sample Size]
Dear all
I have a question.
suppose we do a pilot bio study for a product and it fails (either due to sample size, or due to the formualtion). If the pilot study fails because of the formulation and still we got the clue for the change to be made to formulation and we plan for a direct pivotal study. In this scenario, can we take the intrasubject CV from this failed pilot study for calculation of sample size for pivotal study?
I have a question.
suppose we do a pilot bio study for a product and it fails (either due to sample size, or due to the formualtion). If the pilot study fails because of the formulation and still we got the clue for the change to be made to formulation and we plan for a direct pivotal study. In this scenario, can we take the intrasubject CV from this failed pilot study for calculation of sample size for pivotal study?
Complete thread:
- Failed Pilot Biovelupharm 2007-01-18 07:40
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Failed Pilot Bio Helmut 2007-01-18 11:24
- Failed Pilot Bio velupharm 2007-01-19 12:33
- Failed Pilot Bio Helmut 2007-01-18 11:24
Ing. Helmut Schütz