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

posted by Achievwin – US, 2021-07-06 14:37 (146 d 07:55 ago) – Posting: # 22459
Views: 567

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:-|

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