PK comparability study in case of non-linear PK [Regulatives / Guidelines]
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
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
Complete thread:
- PK comparability study in case of non-linear PKmartin 2016-09-01 17:08 [Regulatives / Guidelines]