Dose normalization [Study Per­for­mance]

posted by Yura – Belarus, 2021-05-27 12:25 (122 d 18:27 ago) – Posting: # 22372
Views: 787

Hello everybody!
There is such a question: if the drug dose is calculated on the basis of the patient's body surface area, how can one take into account the fact that some patients will not receive the actual dose, but will receive a smaller dose when assessing BD / BE (2x2x2 design)? Is it necessary in this case to use corrections when estimating the PK parameters (how to carry out normalization)? For example, the patient will receive a dose of 30mg instead of the current 50mg.:
BSA(m2) Actual Dose  Dose for study
…           30            30
…           40            30
…           50            30
…           60            60
…           70            60
…           80            60
…           90            90

Do you need to check for BSA homogeneity of two groups of sequences?
Thank you

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