Bioequivalence and Bioavailability Forum

Dear colleagues,

I would be happy to get the opinion from the forum members on the following topic:

- Reference product is administered as IV infusion
- Test product (modified formulation) is also administered as IV infusion

Challenge: Reference product indicates non-linear PK (MM).

Any ideas on the design of the PK comparability study (EU and US) taking the regulatory requirements into account would be highly appreciated.

Best regards

Martin