Bioequivalence and Bioavailability Forum

Dear Mr. Chirag,

❝ Sigma_wr is the estimated within subject standard deviation (estimated from the ANOVA on the log scale)

Sigma_WR is estimated within subject standard deviation of the Reference product.

❝ My question is - Since we have two set of data for R, which data set should be used to calculated Sigma_wr. Either of them can be used or we have to take average of both the sets.

Since you have to calculate Sigma_WR, According to my Knowledge you have to use both the set of data for R. Otherwise how will you calculate intra subject standard deviation for reference product.
If you use both the data set for R only then you can compare the responses (Cmax, AUC etc.) for one subject resulting from administration of reference product (R) at two different periods.

Hope this will help.