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RegisterParallel design in groups [Design Issues]
Dear all,
Good afternoon.
Does US FDA accepts two groups seperated by time period in parallel design i.e, if study is planned with a sample size of 120 subjects in parallel design, initially study was planned with 60 subjects (group-1) and after one month gap study was planned with 60 subjects (group-2)?.
As per USFDA Guidance for Industry, Statistical Approaches to Establishing Bioequivalence, 2001 section VII A, crossover study can be carried out in two or more groups of subjects. Does this criteria can be followed for parallel design studies?
Regards,
Rana.
Good afternoon.
Does US FDA accepts two groups seperated by time period in parallel design i.e, if study is planned with a sample size of 120 subjects in parallel design, initially study was planned with 60 subjects (group-1) and after one month gap study was planned with 60 subjects (group-2)?.
As per USFDA Guidance for Industry, Statistical Approaches to Establishing Bioequivalence, 2001 section VII A, crossover study can be carried out in two or more groups of subjects. Does this criteria can be followed for parallel design studies?
Regards,
Rana.
Complete thread:
- Parallel design in groupsrana 2013-07-03 12:41
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Yes and no Helmut 2013-07-03 13:32
Ing. Helmut Schütz