Bioequivalence and Bioavailability Forum

❝ is it mandate to conduct fasting and fed both study for EU submission?

Fasting studies are generally recommended for EU submission since fasting is considered as most sensitive condition to detect potential differences between formulation. However, for products where the SmPC recommends intake of the reference medicinal product only in fed state, the bioequivalence study should generally be conducted under fed conditions.
However, for products with specific formulation characteristics (e.g. microemulsions, solid dispersions), bioequivalence studies performed under both fasted and fed conditions are required unless the product must be taken only in the fasted state or only in the fed state. Reference

Dear Auditor!

❝ Can any one tell me what is the procedure to get reference drug selection for Europe submission. is there any updated RLD list like US FDA.

There's no 'EU RLD'! For a European submission for marketing authorisation an innovator's product from any European member state may be used as a reference. You may get the reference product details in country specific sites.


Regards,

Vardhan.P
Clinical Scientist