Multiple dose design Sample size [Power / Sample Size]

posted by dshah  – India/United Kingdom, 2020-10-20 08:43 (773 d 16:53 ago) – Posting: # 22033
Views: 1,336

Dear Researcher 101,

If you have performed any single dose study, its best to perform Superposition as per SmPC/ PI instruction. Then perform the stat at Steady state- you will know the %CV for all the required parameter and then take a call.
Mostly- based on theoretical assumption, the %CV will come less in multi dose for this phenomena.
Regards,
DShah

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