Achievwin
★    

US,
2021-07-06 16:37
(631 d 11:56 ago)

Posting: # 22459
Views: 1,067
 

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

Post reply
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:-|
 
dshah
★★  

India/United Kingdom,
2021-07-17 13:46
(620 d 14:47 ago)

@ Achievwin
Posting: # 22475
Views: 789
 

 BE for a drug dosed on body weight

Post reply
Dear Achievwin!
If the study is crossover, then the dose administered would generally be same for that subject and thus we could assume that it would not have any impact.
Regards,
Dshah
 
UA Flag
Activity
 Admin contact
22,557 posts in 4,724 threads, 1,607 registered users;
16 visitors (1 registered, 15 guests [including 9 identified bots]).
Forum time: 04:34 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