OT: BW in ANCOVA [Regulatives / Guidelines]

posted by Kumarnaidu2 – India, 2021-03-05 14:56 (204 d 16:44 ago) – Posting: # 22247
Views: 993

Dear All,
I have one query, In PK bio-similarity study in healthy volunteer if the recommended dose is as per bodyweight (say 5mg/kg) then in this case subject with higher bodyweight will receive more total dose as compared to the subject with lower bodyweight. Will this going to impact the serum drug level? If yes then what corrections we need to apply?

Thanks in advance

Complete thread:

Activity
 Admin contact
21,700 posts in 4,538 threads, 1,542 registered users;
online 18 (0 registered, 18 guests [including 5 identified bots]).
Forum time: Sunday 08:40 CEST (Europe/Vienna)

A central lesson of science is that to understand complex issues
(or even simple ones), we must try to free our minds of dogma and
to guarantee the freedom to publish, to contradict, and to experiment.
Arguments from authority are unacceptable.    Carl Sagan

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