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

posted by Alyssa – Malaysia, 2020-05-04 11:26 (942 d 13:59 ago) – Posting: # 21392
Views: 7,155

Dear Dr. Dan,

Thanks for your reply.

❝ I guess you are talking about an oral IR formulation, right?

Is a oral MR formulation.

❝ 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.

The CRO we used for pilot study is the same as per the one used in the published literature (sponsor mentioned the CRO name in the PAR). Therefore, the study procedure performance and bioanalytical method variability is reduced.

❝ 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

Cost is definitely a matter for us now, especially during this Covid-19 pandemic, have to spend wisely. Therefore i need some expert opinion here for my consideration. :confused:

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]

Complete thread:

UA Flag
 Admin contact
22,426 posts in 4,694 threads, 1,600 registered users;
15 visitors (0 registered, 15 guests [including 4 identified bots]).
Forum time: 00:26 CET (Europe/Vienna)

The rise of biometry in this 20th century,
like that of geometry in the 3rd century before Christ,
seems to mark out one of the great ages or critical periods
in the advance of the human understanding.    R.A. Fisher

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