Log in
RegisterWilliams' Design [Design Issues]
Dear Helmut,
we have a study with William's design now with only 8 subjects (as every guidelines say BE study should be done with minimum of 12 subjects, IS IT ETHICAL to do study with 8 subjects) with 3 test formulations (T1, T2, T3) and one reference. I don't know why sponsor want to do study with so few subjects ? pre-pivotal, to know which of his test fomulation is having good bioavailability in comparision to reference. Is it possible to do statistical analysis with pk samples of just 4 subjects as in this situation (2T1&2R, 2T2&2R, 2T3&2R).
with regards
Ram Mohan
we have a study with William's design now with only 8 subjects (as every guidelines say BE study should be done with minimum of 12 subjects, IS IT ETHICAL to do study with 8 subjects) with 3 test formulations (T1, T2, T3) and one reference. I don't know why sponsor want to do study with so few subjects ? pre-pivotal, to know which of his test fomulation is having good bioavailability in comparision to reference. Is it possible to do statistical analysis with pk samples of just 4 subjects as in this situation (2T1&2R, 2T2&2R, 2T3&2R).
with regards
Ram Mohan
Complete thread:
- Four way crossover study roody 2005-10-17 05:50 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Williams' Design Helmut 2005-10-17 12:45
- Williams' Design drrammohanj 2007-12-15 10:09
- Williams' Design Helmut 2007-12-15 13:21
- Williams' Designdrrammohanj 2007-12-18 17:36
- Pilot study in 8 subjects?! Helmut 2007-12-18 18:07
- Williams' Designdrrammohanj 2007-12-18 17:36
- Williams' Design Helmut 2007-12-15 13:21
- Williams' Design drrammohanj 2007-12-15 10:09
- Williams' Design Helmut 2005-10-17 12:45
Ing. Helmut Schütz