Bioequivalence and Bioavailability Forum

Hi

❝ My question is for drugs where dosing is to be done based on the body weight/Body surface area (BSA) etc

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❝ [2] If your answer for above question is yes do we need to do the dose normalization to account for difference in the dose administered (like Cmax/Dose or any other derivatization of PK metrics).

These points were discussed in this post.

❝ [3] What to do if my study is parallel??? Because the dose administered to subjects in both the cohorts will be different

Be it Crossover or parallel study, best way is to use all the volunteers data and add the different dose based on volunteers BSA while calculating the the PK parameters (While doing NCA in Model → Dosing Regimen).

Hope this will help!

Regards