BE for a drug dosed on body weight [Study Per­for­mance]

posted by Achievwin – US, 2021-07-06 16:37 (631 d 12:17 ago) – Posting: # 22459
Views: 1,067

Has anyone have experience in designing bioequivalence trial for a (oncology or other) drug which dosing varies with body weight (varying doses)? How do you present PK across subjects receiving varying doses (dose normalize to a bench mark dose? or since BE is based on ratio it has no impact?)

Thanks for any feed back:-|

Complete thread:

UA Flag
Activity
 Admin contact
22,557 posts in 4,724 threads, 1,607 registered users;
17 visitors (0 registered, 17 guests [including 11 identified bots]).
Forum time: 04:54 CEST (Europe/Vienna)

A scientist’s aim in a discussion with his colleagues
is not to persuade, but to clarify.    Leo Szilard

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