steady state in WinNonlin (example) [Software]

posted by pkpdpkpd – 2007-04-05 17:39 (5608 d 18:14 ago) – Posting: # 635
Views: 15,696

Dear Helmut,

Thanks once again.

» OK, ANOVA is not included in WinNonlin; you will have to fight through a Linear Mixed Effects Model (which is always a little bit tricky). One hint: all effects are fixed!
» Since I haven't done this myself yet, maybe another member of the forum can fill in the gap?
» ...or ask Pharsight's support - and be patient!

It's true. LinMix is a catastrophy and I am fighting through it. Till now not very succesfull. BEBAC members: please, help!!!

» I know some colleagues are using repeated measures ANOVA; I never could understand why.
» The outcome is always a yes/no result.
» What if you get a significant result - would you really throw away the entire study?
» If you are testing individual subjects, you have the option - providing you have stated such a procedure in the protocol - to exclude only these subjects from the evaluation since they did not reach steady state.

An interesting approach. Till now (I am pretty fresh) have not seen any protocols with individual assessment of the achievment of steady state. Is it because it is more time consuming???? And what is about multiple comparisons in this case?

» » In the linear regression while assessing the slope, should it be 95% or 90% CI?
»
» 95% since p = 1-alpha, where alpha=0.05. This is only a convention.
»
» In BE we are only using a 90% CI, because in patients BA of the test can either be lower (5%) or higher (5%) then BA of the reference.
» Therefore the individual patient's risk is kept at 5%.

Does it mean, that I use 95% CI when I assess steady state by subject and 90% CI when I assess by entire study?

PKPDPKPD

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