Bioequivalence and Bioavailability Forum

Dear balakotu,

❝ How to calculate Sample Size by Using SAS Program for Partial and full replicate study designs for Europe and USA Regulatory.

I assume that you would go for scaled ABE with these designs.
AFAIK there is no out of the box solution if you insist in using .

To cite the both Laszlo's [1]:
"Overall, the statistical properties of the methods proposed by EMA and FDA are rather complex as a result of the additional conditions and requirements (mixed procedure, GMR constraint, and (for EMA) a cap on the limits). Furthermore, the tests required by both EMA and FDA are dependent on each other which makes the theoretical treatment very complicated. Therefore, the required sample sizes were obtained by simulations."
(emphasis by me)

So the only way to calculate the sample size is to implement the simulation of replicate crossover design data in SAS, implement the statistical evaluation methods of scaled ABE according to the regulatory body and vary the sample size until your simulations with that sample size give you your desired power.

I suspect that implementation in SAS is a hard job and I suspect further that the run time is tremendous.
There must be a reason that the Laszlo's had implemented theirs in Matlab or earlier in Fortran.

Thus I don't see a great chance that anybody will come out with SAS code to accomplish this task .

At the moment you have to stick with the sample size tables given in the paper [1] of the two Laszlo's.

If you won't go with scABE but with conventional ABE I recommend you to have a look at R-package PowerTOST. It should not so hard to implement the methods used in that package using the undocumented SAS function OwenQ(t,delta,0,R,df).

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[1] Laszlo Tothfalusi and Laszlo Endrenyi
"Sample Sizes for Designing Bioequivalence Studies for Highly Variable Drugs"
J Pharm Pharmaceut Sci (www.cspsCanada.org) 15(1) 73 - 84, 2011