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

posted by Achievwin – US, 2021-07-06 16:37 (1416 d 16:58 ago) – Posting: # 22459
Views: 3,302

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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Pharmacokinetics may be simply defined as
what the body does to the drug,
as opposed to pharmacodynamics, which may be defined as
what the drug does to the body.    Leslie Z. Benet

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