Bioequivalence and Bioavailability Forum

Hi Shatha,

❝ ❝ 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?

Any confirmatory test has to have consequences. If a test is only exploratory, no problems. However, since it is a pre­re­qui­site for a valid comparison that (pseudo-)steady-state is achieved, I would avoid any test – which is not required.

❝ ❝ 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.

❝ 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?

Hey, you discovered Alfredo’s presentation on the web. 

Just checked all others (links in this post): nothing. However, it was a response by the panelists (all members of the PKWP) to a question of an attendee.

I know that other members of the forum attended this meeting as well. If you don’t believe me, maybe they can join the conversation and confirm that.

See also the end of section 1 in this post which I wrote three days after the meeting when my memory was fresh.

❝ Please see the article and graph

THX. Where does the graph come from?

P.S.: Please don’t format your entire text in green.