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RegisterDosing on beds or in separate dosing room? [Study Performance]
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
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
Complete thread:
- Dosing on beds or in separate dosing room?cr.maroj 2013-10-01 13:47
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Dosing on beds or in separate dosing room? jag009 2013-10-01 15:20
- Dosing on beds or in separate dosing room? Dr_Dan 2013-10-02 10:20
- Dosing on beds or in separate dosing room? drgunasakaran1 2013-10-03 04:34
Ing. Helmut Schütz