Bioequivalence and Bioavailability Forum

Hi Tekwani,

❝ If 90% confidence interval falls between 80-125% for only Cminss but not for Ctauss, what justification can be given?

You have to evaluate the study according to the protocol. But: EMA’s definition was given in the 2013 MR draft and already 2010 in the comments to the IR BE-GL (“By C_min,ss we mean the con­centration at the end of the dosage interval”). Nothing really new.

❝ Can it be justified that the submission is done before the implementation of new MR guideline (which is effective from 1 June 2015), so 90% CI of Cminss should be considered?

That’s not a justification, but some organizational chitchat. Even if you claim that you were not aware of the new metric (and therefore, the study was not powered to show BE for it), you could try to scale the limits. See this post.

---

PS: In the past comments were published together with final guidelines. MR-GL? Nothing so far.