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RegisterUnderrepresentation of female subjects in BE study to register Generic [Regulatives / Guidelines]
Hi ElMaestro,
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?
» Yes, you can likely conduct the study in males. But why would you if you think the conclusion in males can be extrapolated
Cheers,
SKM
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?
» Yes, you can likely conduct the study in males. But why would you if you think the conclusion in males can be extrapolated
Cheers,
SKM
Complete thread:
- Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-11 14:35 [Regulatives / Guidelines]
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- 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