Bioequivalence and Bioavailability Forum

Hello Krishna!

❝ Iam new to industry....

Welcome to the club

❝ How can i findout the number of subjects required for pivotal study using the information of CV and T/R ratio from pilot SAS software...

Have a look at this paper.

Although IMHO firing up SAS is breaking the fly on the wheel…
There are already tables published (giving exact results), but if you have SAS handy… – and don’t forget to validate your routine!

For the ‘conventional’ acceptance range of 0.8 to 1.25:

Diletti E, Hauschke D and VW Steinijans
Sample size determination for bioequivalence assessment by means of confidence intervals
Int J Clin Pharm Ther Toxicol 29/1, 1-8 (1991)

For narrower and wider acceptance ranges:

Diletti E, Hauschke D and VW Steinijans
Sample size determination: Extended tables for the multiplicative model and bioequivalence ranges of 0.9 to 1.11 and 0.7 to 1.43
Int J Clin Pharm Ther Toxicol 30/Suppl.1, S59-62 (1992)