Sample size calculation (Pilot study result vs literature) [Power / Sample Size]

posted by Dr_Dan  – 2020-05-04 06:46  – Posting: # 21391
Views: 3,700

Dear Alyssa
I guess you are talking about an oral IR formulation, right?
ISCV are not carved in stone, there will always be a certain variability. However, big differences hint on differences in study performance and/or quality of formulations. It is reasonable to assume that the ISCV in the pivotal study will be similar to the pilot study if you use the same CRO (study procedure performance), the same test formulation vs. the same (batch of) reference product and the same bioanalytical method. If costs do not matter you can of course follow the suggestion of the CRO to go for 4 way crossover, replicate design, with ratio 90-111%, ISCV = 35-40%. :-D:-D:-D
I hope this helps

Kind regards and have a nice day
Dr_Dan

Complete thread:

Activity
 Admin contact
20,648 posts in 4,328 threads, 1,436 registered users;
online 21 (1 registered, 20 guests [including 12 identified bots]).
Forum time: 08:20 UTC (Europe/Vienna)

Freedom is always and exclusively
freedom for the one
who thinks differently.    Rosa Luxemburg

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5