Subject-by-formulation interaction variance analysis in SAS [Regulatives / Guidelines]

posted by KR – India, 2014-12-18 13:28 (4211 d 07:11 ago) – Posting: # 14106
Views: 4,592

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

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