Posting: # 16459
According draft guidance on hydrocortisone (Nonbinding Recommendations on Hydrocortisone) FDA recommends a 4 mg dose of dexamethasone administered 10 hours prior to drug administration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.
@ Mauricio Sampaio
Posting: # 16460
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