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

posted by Dr_Dan  – 2020-05-04 08:46 (176 d 13:32 ago) – Posting: # 21391
Views: 5,174

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
21,179 posts in 4,414 threads, 1,474 registered users;
online 6 (0 registered, 6 guests [including 4 identified bots]).
Forum time: Tuesday 21:19 CET (Europe/Vienna)

No computer has ever been designed
that is ever aware of what it’s doing;
but most of the time, we aren’t either.    Marvin Minsky

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