Dose normalization [Study Per­for­mance]

posted by mittyri – Russia, 2021-05-31 12:42 (20 d 20:35 ago) – Posting: # 22382
Views: 257

(edited by mittyri on 2021-05-31 18:21)

Dear Yura,

» Patients will take different doses depending on the calculated BSA (for example, 30 - 60 - 90 - do not consider "actual" doses for now). And when assessing, there is no need to do normalization, for example, for a single dose of 30mg?

I cannot remember any examples where dose normalization was recommended by authorities. Indeed, there are contrary examples here and here.
mainly due to the fact that the volunteer's data controls itself in crossover studies

But you should be aware of the case with different strengths aka different products (i.e. 50+10 mg, 40 mg) - see here
AFAIK in such case there's no good solution.

Kind regards,
Mittyri

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