Consult animal trial design [Design Issues]

posted by libaiyi – China, 2024-07-03 13:52 (14 d 13:31 ago) – Posting: # 24059
Views: 379

Hello everyone,

I am currently conducting a biosimilar trial for a drug and have received a question from a regulatory agency regarding how to evaluate the PK similarity with the reference product based on non-clinical pharmacokinetic parameters. How can I address this question using animal studies? Is there an animal BE trial?

Thank you!

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