Sample Size Estimation for (Bio)equivalence Testing Between Two Treatments
نویسنده
چکیده
Standard 2X2 and replicated 2X2m crossover designs are recommended in the regulatory guidelines to establish bioequivalence of generic drug with off patent brand-name drug. Estimation of sample size, in any clinical trial, targets to optimize the resource usage with assurance of having adequate probability (power) to get significant result. This paper discusses the statistical concept behind sample size estimation for 2X2 and 2X2m bioequivalence trials along with its implementation in SAS. Procedure of sample size estimation in SAS has been discussed through some simple datastep functions (%BESS, %BESSm and %BESSg) and PROC POWER, a procedure for calculation of sample size. To assess the accuracy of these macros and PROC POWER, estimated sample size obtained through these two procedures have been compared with those estimated by Diletti et. al.(1991). It has been observed that sample size obtained through macros and PROC POWER is matching almost perfectly with those obtained by Diletti et. al.
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