Bioequivalence and Bioavailability Forum

Dear Suri!

It seems that you have (mis)used some piece of software. Which one? Or if a general statistical package was used, which program/macro/routine? Some programs give the number of subjects / sequence, others the total...
Just to give you an idea:

❝ Paired equivalence method:

❝ sample size-> Paired equivalence->multiplicative

❝ 1) multiplicative

❝ Cv=0.62 T/R=0.95 POWER=0.80, LOWER=0.80 UPPER=1.25 then N=72

I guess you want to know the total sample size in a 2×2×2 cross-over design with CV_intra of 62% (=0.62)?
142 subjects are needed (or 71 / sequence).

❝ which method we have to take for finding sample size in BA/BE.

Sample size calculation depends on

• the design (cross-over, paired, parallel),
• the statistical model (multiplicative for AUC, C_max, additive for Ae, MRT), and
  • CV (-intra for cross-over, -total for parallel),
    
  • the expected deviation of test from reference Δ,
    
  • α (patient's risk),
    
  • and power π (where β = 1 – π = producer's risk).

❝ Which method is accepted by regulators.

Any one – if the method is suitable for the design.