Log in
RegisterSampling Time Point Deviation in EMEA study [Regulatives / Guidelines]
Hi all,
As per our protocol, we used post dose samples will be collected with an allowed window period of + 02 minutes from the scheduled time in case of in-house samples and of ± 1hour in case of ambulatory visit sample.
But as per EMEA guideline, Actual time of sampling should be used in the estimation of the pharmacokinetic parameters.
Then, my query is
Do we have to provide +02 minutes window period while collection of post samples in EU submission studies or not?
Thanks & Regards,
Sandy
As per our protocol, we used post dose samples will be collected with an allowed window period of + 02 minutes from the scheduled time in case of in-house samples and of ± 1hour in case of ambulatory visit sample.
But as per EMEA guideline, Actual time of sampling should be used in the estimation of the pharmacokinetic parameters.
Then, my query is
Do we have to provide +02 minutes window period while collection of post samples in EU submission studies or not?
Thanks & Regards,
Sandy
Complete thread:
- Sampling Time Point Deviation in EMEA studysandipmumbai 2013-06-28 10:59
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Sampling Time Point Deviation in EMA study Ohlbe 2013-06-28 11:27
Ing. Helmut Schütz