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RegisterUnderrepresentation of female subjects in BE study to register Generic [Regulatives / Guidelines]
Hi,
» 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.
FDA? Even if not FDA I don't think your justification will work. You are trying not to use female subjects because they caused your study to fail. That alone is not a good justification.
J
» 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.
FDA? Even if not FDA I don't think your justification will work. You are trying not to use female subjects because they caused your study to fail. That alone is not a good justification.
J
Complete thread:
- Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-11 14:35 [Regulatives / Guidelines]
![[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 Genericjag009 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