Strategies to establish the BE changing the physiological behavior [Study Per­for­mance]

posted by Mauricio Sampaio  – Brazil, 2016-06-29 04:47  – Posting: # 16459
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Dear members...

According draft guidance on hydrocortisone (Nonbinding Recommendations on Hydrocortisone) FDA recommends a 4 mg dose of dexamethasone administered 10 hours prior to drug administration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
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