Concerta Guidance: Sub x Form inter­action variance test [Regulatives / Guidelines]

posted by jag009  – NJ, 2014-12-07 21:58 (3421 d 10:59 ago) – Posting: # 14005
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(edited by jag009 on 2014-12-07 22:10)

Hi folks,

❝ I’m thinking “yes”. IMHO it’s the difference of the between- and pooled within-subject variances. Even in 2×2 cross­overs sometimes CVintra > CVinter...


I used the ema 4 way fully replicate dataset (Cmax) (I don't have the link now but I am sure you know what I am referring to) and tried it with my revised FDA RSABE SAS code. Briefly I obtained withsubject variances for T & R from dlats and the withinsubject variance for I from ilat (this might be my problem?). As per concerta guidance the sub*form interaction variance is,

Mi - 0.5* (Mt + Mr).

Using this formula my value was -0.074978. Can someone try this with SAS and let me know? Oh my withinsubject variances for T and R were 0.11654 and 0.19931. The withsubject variance for I was 0.08295 from ilat.

Update: I think I know what my potential problem is... I think I misinterpreted the withinsubject variance for I. For withinsubject variance T & R, is derived from estimate/2 in SAS, but for I its just the estimate?

Sorry I am typing from a tablet... ;-)

John
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