Bioequivalence and Bioavailability Forum • Subject-by-formulation interaction variance analysis in SAS

KR
★

India,
2014-12-18 13:28
(3413 d 20:38 ago)

Posting: # 14106
Views: 3,412

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

Helmut
★★★

Vienna, Austria,
2014-12-18 14:41
(3413 d 19:25 ago)

@ KR
Posting: # 14107
Views: 2,820

S×F: search!

Post reply

Hi KR,

❝ Hello Sir,

▲ Sexist?

Please search the Forum before posting. There are even two threads on the entry page: #13848, #13991. Obviously no solution yet.

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

The former (“[…] the recommended allowance for σ²_D is 0.03”). Why one has to estimate the upper 95% CL – without assessing it – remains FDA’s secret. Ask them and report back.

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