Bioequivalence and Bioavailability Forum

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