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RegisterUnderrepresentation of female subjects in BE study to register Generic [Regulatives / Guidelines]
Dear All,
I request your help to arrive at a decision on male to female ratio in a BE trial. We have done a pilot study with 12 subjects (8 male and 4 female) and the results didn't meet the bioequivalence criteria. However, when we exclude the female data it marginally meets the bioequivalency crtieria of 80%-125%.
Can we conduct the pivotal study only in Males? Can we extrapolate the conclusions obtained in males to females. What would be the regulatory challenges and please prove some references that can guide me on this.
Thanks a lot for your support.
Best wishes,
SKM
I request your help to arrive at a decision on male to female ratio in a BE trial. We have done a pilot study with 12 subjects (8 male and 4 female) and the results didn't meet the bioequivalence criteria. However, when we exclude the female data it marginally meets the bioequivalency crtieria of 80%-125%.
Can we conduct the pivotal study only in Males? Can we extrapolate the conclusions obtained in males to females. What would be the regulatory challenges and please prove some references that can guide me on this.
Thanks a lot for your support.
Best wishes,
SKM
Complete thread:
- Underrepresentation of female subjects in BE study to register Genericping4santosh 2020-03-11 14:35
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Underrepresentation of female subjects in BE study to register Generic Ohlbe 2020-03-11 15:07
- Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-11 15:37
- Study planning 101 Helmut 2020-03-11 16:31
- Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-11 15:37
- Underrepresentation of female subjects in BE study to register Generic ElMaestro 2020-03-11 15:24
- Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-11 16:15
- Underrepresentation of female subjects in BE study to register Generic ElMaestro 2020-03-15 09:27
- Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-15 09:41
- Underrepresentation of female subjects in BE study to register Generic ElMaestro 2020-03-15 10:23
- Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-16 09:13
- Not enough subjects to say Ohlbe 2020-03-15 19:28
- Not enough subjects to say ping4santosh 2020-03-16 09:03
- Underrepresentation of female subjects in BE study to register Generic ElMaestro 2020-03-15 10:23
- Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-15 09:41
- Underrepresentation of female subjects in BE study to register Generic ElMaestro 2020-03-15 09:27
- Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-11 16:15
- Underrepresentation of female subjects in BE study to register Generic jag009 2020-03-15 07:30
- Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-15 09:43
- Underrepresentation of female subjects in BE study to register Generic Ohlbe 2020-03-11 15:07
Ing. Helmut Schütz