libaiyi ★ China, 2024-07-03 13:52 (310 d 02:41 ago) Posting: # 24059 Views: 1,416 |
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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! |