Biosimilars [Design Issues]

posted by Kumarnaidu2 – India, 2021-10-22 07:53 (47 d 04:19 ago) – Posting: # 22653
Views: 397

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,


Complete thread:

 Admin contact
21,788 posts in 4,557 threads, 1,548 registered users;
online 7 (0 registered, 7 guests [including 4 identified bots]).
Forum time: Wednesday 11:13 CET (Europe/Vienna)

There is no adequate defense, except stupidity,
against the impact of a new idea.    Percy Williams Bridgman

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