Bioequivalence and Bioavailability Forum • Bioequivalence studies at night

Loky do
★

Egypt,
2022-03-28 14:36
(757 d 13:35 ago)

Posting: # 22875
Views: 1,572

Bioequivalence studies at night [Regulatives / Guidelines]

Dears

Are there any objections (regulatory or in guidelines) or negative effect on the PK of drugs when conducting Bioequivalence studies at night (i.e. volunteers will fast over day and dose will be administrated at night) the dosing hours will be standardized through volunteers and phases? Also the fasting hours before dosing to volunteers as per guidelines are at least 8-10 hours, if it reached 14 hours could it affect the PK of the drug also?

Thanks in advance

dshah ★★ India/United Kingdom, 2022-03-28 16:23 (757 d 11:48 ago) @ Loky do Posting: # 22878 Views: 1,232	Bioequivalence studies at night Post reply
	Dear Loky do! If considering circadian rhythm, the dosing at night can be considered for few drugs; but it would be strange to dose in night for other drugs as many factors could play role i.e. sleep cycle. Regards, Divyen