Bioequivalence and Bioavailability Forum

Dear Ravi!

❝ We have conducted a single dose pilot study. My question is can we predict

❝ sample size for Multiple dose pilot study on the basis of estimates (T/R %

❝ and intra cv%) from single dose pilot study?

Yes. But don't forget to allow for the usual safety margins (prediction from a small pilot study [T/R and CV% are uncertain], drop-out rate in any multiple dose study). On the other hand variability in steady-state generally is smaller than after a single dose - but unfortunatelly you have no clue to which extent...

❝ If yes please tell me the formula...

Very difficult (if not impossible to 'do by hand'); see here, also for software and tables in the following posts.

❝ ... and the software from which sample size for Multiple dose study

❝ can be predicted.

David Dubins' FARTSSIE (for Excel 2000+, free). You may also use bear for R (you have to install R first > install bear > load bear > go() >