Subject-by-formulation interaction variance analysis in SAS [Regulatives / Guidelines]
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
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
Complete thread:
- Subject-by-formulation interaction variance analysis in SASKR 2014-12-18 12:28 [Regulatives / Guidelines]
- S×F: search! Helmut 2014-12-18 13:41