Bioequivalence and Bioavailability Forum

Hi Helmut

❝ What will you do if your ‘check’ fails? Since you don’t want to exclude subjects, would you throw the entire study into the waste container?

So, if the test isn't clearly requested, then I don't have to do it in order to avoid any consequences, right?

❝ As I wrote in the article:

In 2013² members of the EMA’s Pharmacokinetics Working Party confirmed unanimously that a test is not expected by the agencies. ‘Demonstration of steady state’ should not be understood in the statistical sense. In­stead, individual pre-dose concentrations should be reported together with spaghetti plots and plots of geometric means. In the discussion it became clear that common sense should prevail.

In an earlier meeting³ nothing was mentioned at all.

❝

❝ For 10+ years I’m presenting only summary tables, individual and spaghetti plots. All regulatory assessors were fine with that.

I don't have access to the Open Forum Discussion, I tried to find reference no. 02 but I only found session 3 https://custom.cvent.com/6E33084F71EB4DD6B892656072736BFB/files/07323e6d219f47cdae68e89f1f508b6b.pdf, which isn't related to steady state achievement. Can you please provide the steady state related session to support protocol deviation/ amendment? Thank you

❝ I can’t follow you here. You stated something in the protocol without knowing how to perform the method? Ask the reviewer for help and report back here. I’m curious.

Please see the article and graph


Thank you