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According draft guidance on hydrocortisone (Nonbinding Recommendations on Hydrocortisone) FDA recommends a 4 mg dose of dexamethasone administered 10 hours prior to drug administration as a pre-treatment to lower endogenous hydrocortisone levels. This procedure in bioequivalence studies is normal? Can I change the phisiological behavior to measure a principal analyte in appropriate biological fluid and determine the bioequivalence between two formulations?
Can I extrapolate this idea, in bioequivalence studies, to reduce the first pass effect using the vasodilator medicines* before the administration of drugs which are highly metabolized? To have a chance to mensure the parent compound (not metabolized) and to establish the bioequivalence result ?
* The use of vasodilator medicines increase the splenic blood flow and reduce the first pass effect.
According draft guidance on hydrocortisone (Nonbinding Recommendations on Hydrocortisone) FDA recommends a 4 mg dose of dexamethasone administered 10 hours prior to drug administration as a pre-treatment to lower endogenous hydrocortisone levels. This procedure in bioequivalence studies is normal? Can I change the phisiological behavior to measure a principal analyte in appropriate biological fluid and determine the bioequivalence between two formulations?
Can I extrapolate this idea, in bioequivalence studies, to reduce the first pass effect using the vasodilator medicines* before the administration of drugs which are highly metabolized? To have a chance to mensure the parent compound (not metabolized) and to establish the bioequivalence result ?
* The use of vasodilator medicines increase the splenic blood flow and reduce the first pass effect.
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