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
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
Complete thread:
- Bioequivalence studies at nightLoky do 2022-03-28 12:36 [Regulatives / Guidelines]
- Bioequivalence studies at night dshah 2022-03-28 14:23