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!

Complete thread:

UA Flag
Activity
 Admin contact
23,107 posts in 4,858 threads, 1,644 registered users;
71 visitors (0 registered, 71 guests [including 6 identified bots]).
Forum time: 03:23 CEST (Europe/Vienna)

All paid jobs absorb and degrade the mind.    Aristotle

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5