Loky do

2022-03-28 12:36
(93 d 06:09 ago)

Posting: # 22875
Views: 626

 Bioequivalence studies at night [Regulatives / Guidelines]


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

India/United Kingdom,
2022-03-28 14:23
(93 d 04:21 ago)

@ Loky do
Posting: # 22878
Views: 468

 Bioequivalence studies at night

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.
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