Bioequivalence and Bioavailability Forum

❝ I just realized the same may apply to Rivaroxaban: According to point 3.6 of EMA's Q&A regulators could ask for a BE study on crushed tablets while the Product Specific Guideline ask "only" for fast (10 mg) and fed (20 mg) studies.

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❝ Could we expect a new version of this Product Specific Guideline?

That's very valid point. As far as I know regulators do ask for such study for mentioned products, referring to Q&A which should be read in conjuction with product specific guidelines. Draft of Apixaban product specific guideline already requires such study, unless justified. It's unknown if EMA will update Riva and Tica guidelines. Anyway, for me this whole concept of product specific guielines makes not much sense, if you still need to verify if finalized gudieline is consistent with current EMA thinking published in other documents. Especially that date of coming of these gudeiline into effect was same as publishing Q&A (NOV 2016). So they were already outdated when coming into effect (!).