Bioequivalence and Bioavailability Forum

Hi ElMaestro!

❝ ❝ If required, a brief scientific rationale for the guidance will be provided.

❝ What does that mean? If required by whom? CHMP? Themselves? People who comment?

Duno. Next question.

❝ I would hope they'd publish rationales in all cases.

Me too. This is lacking in most of FDA’s product-specific guidances.

❝ […] since guidelines are guidelines and not laws, knowing the rationale for each of the PK-workgroup's PSGs would allow applicants to better distinguish between must and should.

Definitely. Did you notice the term “guidance” instead of “guideline”? I have learned from John that – according to FDA’s thinking – the latter is considered more binding that the former. This was one of the reasons renaming the “Note for Guidance on Investigation of Biavailability and Bioequivalence” to “Guideline on Investigation of Bioequivalence”.

I expect EMA to publish guidances on drugs mentioned in the Q&A first (omeprazole, clopidogrel, losartan, tacrolimus, ciclosporine, mycophenolate mofetil).

How far will they reach? Problematic cases only? I don’t expect to see something similar to FDA’s API-specific guidances (currently 1115…).

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Edit 01/2014: Tacrolimus is scheduled for review in 2014 (see here).