Bioequivalence and Bioavailability Forum

❝ This point of the Q&A may be confusing and may clash to what is indicated in the product specific quidelines of some products. An example:

❝

❝ -Ticagrelor: SmPC of Ticagrelor indicates that the tablets can be crushed to a fine powder mixed with 1/2 glass of water and administered. It also allows to administer via nasogastric tube. However the Product specific guideline here ask only for fasting study.

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.

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

Thanks,