Bioequivalence and Bioavailability Forum

Dear all,

Would you mind to answer my question related to Bioequivalence Statistical Analysis ?

Which one is the correct one for SE Difference ?

a. SE Difference = (MS residual x (1/n_TR + 1/n_RT)^1/2

or

b. SE Difference = (MS residual x (2/n)^1/2


Note : n = subject number of Bioequivalence study
nRT = subject number who get Reference Drug in Period 1, and get Test Drug in Period 2 = 1/2 n
nTR = subject number who get Test Drug in Period 1, and get Reference Drug in Period 2 = 1/2 n


If I calculate 2 formula from a and b, the results will be different.

a. SE Difference = (MS residual x (1/n_TR+ 1/n_RT)^1/2
= (MS residual x (1/(1/2n)+ (1/(1/2n)^1/2
= (MS residual x (2/n + 2/n)^1/2
= (MS residual x (4/n)^1/2

b. SE Difference = (MS residual x (2/n)^1/2

Would you mind to share the guideline for SE Difference calculation ?

Thank you

Best Regards

joy_fm