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RegisterUnderrepresentation of female subjects in BE study to register Generic [Regulatives / Guidelines]
Hi ping,
(...)
This could be a case of BE being present in males and not in females. Would you really want to put such a product on the market, if you think the conclusion from males can be extrapolated in such a way that regulators grant approval??
However, those companies that did try to investigate if BE applies in one population but not in another all failed - there are occasional rumours out there but the proof is generally rather absent. I.e. if a product is BE in one gender and not in another, or if a product is BE in a European population but not in an African population etc. Innovators have spent a lot of $$ on investigating it, and no solid proof was delivered so far.
I am thus a little doubtful as to whether you are really having a product with a true gender difference in terms of the BE conclusion.
"More data is needed."
❝ It's not a random flutter. Females actually fall back on bioequivalncy. Cmax at 75% and range was lower too. Pioneer product behaved similar way. So it's not random. You are right. The females also has higher variance.
(...)
❝ I didn't understand your last statement. Can you kindly clarify?
This could be a case of BE being present in males and not in females. Would you really want to put such a product on the market, if you think the conclusion from males can be extrapolated in such a way that regulators grant approval??
However, those companies that did try to investigate if BE applies in one population but not in another all failed - there are occasional rumours out there but the proof is generally rather absent. I.e. if a product is BE in one gender and not in another, or if a product is BE in a European population but not in an African population etc. Innovators have spent a lot of $$ on investigating it, and no solid proof was delivered so far.
I am thus a little doubtful as to whether you are really having a product with a true gender difference in terms of the BE conclusion.
"More data is needed."
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
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 GenericElMaestro 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 GenericElMaestro 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