PK comparability study in case of non-linear PK [Regulatives / Guidelines]

posted by martin  – Austria, 2016-09-01 19:08 (3090 d 01:05 ago) – Posting: # 16620
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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

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