Bioequivalence studies at night [Regulatives / Guidelines]

posted by Loky do – Egypt, 2022-03-28 12:36 (101 d 05:47 ago) – Posting: # 22875
Views: 633

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

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