Achievwin
★★  

US,
2021-07-06 16:37
(1459 d 05:27 ago)

Posting: # 22459
Views: 3,688
 

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

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,
2021-07-17 13:46
(1448 d 08:18 ago)

@ Achievwin
Posting: # 22475
Views: 2,774
 

 BE for a drug dosed on body weight

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
23,427 posts in 4,929 threads, 1,677 registered users;
25 visitors (0 registered, 25 guests [including 11 identified bots]).
Forum time: 22:04 CEST (Europe/Vienna)

Half the harm that is done in this world
Is due to people who want to feel important.    T. S. Eliot

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