Achievwin
★    

US,
2021-07-06 14:37
(20 d 10:10 ago)

Posting: # 22459
Views: 196
 

 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 11:46
(9 d 13:01 ago)

@ Achievwin
Posting: # 22475
Views: 89
 

 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
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