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RegisterStrategies to establish the BE changing the physiological behavior [Study Performance]
Dear Mauricio
If you regard a BE Study as an in-vivo quality test to detect supposed differences in formulations (and which needs not to reflect clinical practice) then I think it should be possible to change the phisiological behavior to measure a principal analyte in appropriate biological fluid and compare the bioavailabilities of two formulations. As long as the BE studies is designed in such way that the formulation effect can be distinguished from other effects it should work.
I hope this helps
If you regard a BE Study as an in-vivo quality test to detect supposed differences in formulations (and which needs not to reflect clinical practice) then I think it should be possible to change the phisiological behavior to measure a principal analyte in appropriate biological fluid and compare the bioavailabilities of two formulations. As long as the BE studies is designed in such way that the formulation effect can be distinguished from other effects it should work.
I hope this helps
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Strategies to establish the BE changing the physiological behavior - Mauricio Sampaio, 2016-06-29 06:47
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Strategies to establish the BE changing the physiological behavior - Dr_Dan, 2016-06-29 18:01
Ing. Helmut Schütz