OT: BW in ANCOVA [Regulatives / Guidelines]

posted by Kumarnaidu2 – India, 2021-03-05 15:56 (1539 d 16:00 ago) – Posting: # 22247
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Dear All,
I have one query, In PK bio-similarity study in healthy volunteer if the recommended dose is as per bodyweight (say 5mg/kg) then in this case subject with higher bodyweight will receive more total dose as compared to the subject with lower bodyweight. Will this going to impact the serum drug level? If yes then what corrections we need to apply?

Thanks in advance

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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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