Bioequivalence and Bioavailability Forum

Dear All,

First of all, HAPPY NEW YEAR to all...!!!

I have question in my mind from many days...How can we calculate sample size for a replicate study, which has more than two replicates for each treatments?

In recent days, I am working on In Vitro Permeation Test (IVPT) studies. These study designs are as same as Full replicate study design with more than two replicates for each treatment. Please see the draft guidance on acyclovir for further details.

I am trying to calculate the sample size based on Full replicate study sample size calculation. i.e., (2*sample size for replicate study)/no. of replicates required for IVPT study.

I saw one post by Helmut on SAAMnow Spring 2019 Workshop. This topic was covered in this conference. I have searched a lot for the presentations this conference, unfortunately I didn't get anything.

Anybody in the forum who had knowledge on this topic, please help me.

Also, how to do power calculation for these studies?

Thanks in advance.