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RegisterUnderrepresentation of female subjects in BE study to register Generic [Regulatives / Guidelines]
Dear SKM,
So what ? It is a pilot. Was it powered to demonstrate BE ?
Did you pre-plan this male-only analysis in your protocol or statistical analysis plan ?
Where do you intend to submit your data ? USA: the FDA wants males and females. Europe: EMA accepts studies in males only, but "we fear that we may fail if we include females" will not be an acceptable rationale.
❝ We have done a pilot study with 12 subjects (8 male and 4 female) and the results didn't meet the bioequivalence criteria.
So what ? It is a pilot. Was it powered to demonstrate BE ?
❝ However, when we exclude the female data it marginally meets the bioequivalency criteria of 80%-125%.
Did you pre-plan this male-only analysis in your protocol or statistical analysis plan ?
❝ Can we conduct the pivotal study only in Males?
Where do you intend to submit your data ? USA: the FDA wants males and females. Europe: EMA accepts studies in males only, but "we fear that we may fail if we include females" will not be an acceptable rationale.
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Underrepresentation of female subjects in BE study to register Generic ping4santosh 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 GenericOhlbe 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 GenericOhlbe 2020-03-11 15:07
Ing. Helmut Schütz