libaiyi
★    

China,
2024-07-03 13:52
(367 d 21:11 ago)

Posting: # 24059
Views: 1,757
 

 Consult animal trial design [Design Issues]

Post reply
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!
 
UA Flag
Activity
 Admin contact
23,427 posts in 4,929 threads, 1,675 registered users;
37 visitors (0 registered, 37 guests [including 18 identified bots]).
Forum time: 11:03 CEST (Europe/Vienna)

Many people tend to look at programming styles and languages like religions:
if you belong to one, you cannot belong to others.
But this analogy is another fallacy.    Niklaus Wirth

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