EMA: No problems with many sampling time points… [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2023-06-28 17:59 (334 d 02:01 ago) – Posting: # 23633
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Hi Divyen,

❝ ❝ […] Good luck in sampling every five minutes. :thumb down:

❝ But will increase in sampling lead to higher blood loss and then proposal to reduce sampling by IRB/IEC? Or will there be any hope of great BA method so that sampling at every 5/10 min is feasible with minimal blood loss?

Just to quote the overview of comments to the ibuprofen guidance:

Comment: This will lead to credible feasibility and ethical concerns.
Outcome: Every 5 minutes around Tmax is enough. Every 15 minutes is the standard frequency, therefore, there is no critical change. No ethical concern is anticipated if the volume of blood is not excessive. The present bioanalytical methods allow to sample less than 300 ml of blood in total in studies with up to 25 samples. Therefore a few more samples for a proper characterisation of Tmax and Cmax are not considered an ethical problem.

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