OT: BW in ANCOVA [Regulatives / Guidelines]

posted by Kumarnaidu2 – India, 2021-03-05 14:56 (42 d 15:24 ago) – Posting: # 22247
Views: 354

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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