Bioequivalence and Bioavailability Forum

Hello everybody and a nice evening.

From my point of view and experience, the discussion on narrow therapeutic drugs seems to be becoming more and more important. However, I just wanted to point on one issue. Actually, I just registered for this; always wanted but needed a little push.

The problem for the greater part evolves from

❝ "As described for the solution, the intra- and inter-individual variability in trough levels is high (40-50%)"

, doesn't it. But trough values (roughly Cmin) not only might show higher variability in general but, at least in Europe, are not a parameter in BE assessment for IR formulations.
Don't hesitate to correct me here, maybe I missed just something important?
Based on this I would recommend to reconsider the basis of the sample size estimation (back to literature).

With best regards,

Relaxation.

Edit: Okay, I screwed it up. Any chance someone might move this to the end of the thread .

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Edit: Welcome to the club! I think you posted in the right place, because you replied to and quoted Jo's post. If you still want, I can link the post to mine. Simply reply with yes/no. BTW, you are absolutely right about C_min for IR formulations. [Helmut]

Edit: Thanks for the welcome. Yes, I would prefer a placement closer to the end. Might have to get used to the wiki-style-"post to the post", though.
Thanks a lot.

Edit: Moved. [Helmut]