Biosimilars [Design Issues]

posted by Kumarnaidu2 – India, 2021-10-22 09:53 (915 d 08:38 ago) – Posting: # 22653
Views: 1,659

Dear All,

For a medicinal product to be administer as intravenous infusion (for approx. 3 hrs) if we consider Ctrough as one of the primary pk parameter for demonstrating PK similarity, does different rate of infusion amongst enrolled subjects has any impact on Ctrough levels?

Thanks in advance,

Kumar

Complete thread:

UA Flag
Activity
 Admin contact
22,993 posts in 4,828 threads, 1,659 registered users;
63 visitors (0 registered, 63 guests [including 3 identified bots]).
Forum time: 18:31 CEST (Europe/Vienna)

So far as I can remember,
there is not one word in the Gospels
in praise of intelligence.    Bertrand Russell

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