Bioequivalence and Bioavailability Forum

Hi,

Could you please let me know your opinion, is dosing in a room separate from the clinic permissible? or dosing must always be done on subjects' bed only in sitting position?

If dosing is done in a separate room, as subjects walk to their beds following the dosing, will it not affect PK/ variability?

The protocol requirement is subjects need to be in semi-reclined position for the first 4 hours. So, as subjects walk following the dosing, will this become a protocol deviation?

I tried to look for any regulatory requirement (MHRA) but couldn't find. Kindly let me know if there is any guidance available.

Thanks,
CR