Bioequivalence and Bioavailability Forum

Hello Sir,

Can you please let me know how we can calcualate subject-by-formulation interaction variance analysis in SAS, which is required as per the new Methylphenidate ER Tablets BE guidacne comment no. 02 (path of the guidance is given below) ?

Path of the guidance: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm320007.pdf

Also, please confirm whether the recommended allowance of 0.03 is for sigma_d^2 or 95% upper confidence bound for sigma_d^2 ?

Thanks,

KR