Bioequivalence and Bioavailability Forum

Dear D. Labes!

THX for the comparison; differences* to WinNonlin’s results only in the last decimal place…

Maybe some SAS-believing regulator reads your results. Excuse my bold format:

Smaller CV, tighter CI, anticonservative, liberal,
serious risk to the public health.

❝ Dear Helmut, interpret I your sentence above

❝ ❝ If you want to follow the EMA’s method (which I would not recommend!) in the answer to Dan right if I assume you would recommend the full model / dataset for evaluation even if the study is targeted to EMA? Who is afraid of EMA?

It depends whether you have guts or not. I would not use amputee’s statistics – and make the rationale clear in the protocol. It's one of the basic assumptions in a non-repli­cated cross-over study to have IDD – or a common variance. If the authority rejects to approve the protocol (based on the GL), it’s their responsibility to increase patient’s risk in an unpredictable manner. Dan’s example would call for two SAPs (correct model for FDA and beheaded ‘model’ for EMA), IMHO.

In the meantime I still hope for some kind of clarification (a Q&A or what­soever) from the almighty oracle EMA.

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• Edit 2012-07-18: Identical results for response1 compared to SAS in Phoenix/Win­Non­lin 6.3 with all fixed effects:
  Model    PE         90% CI          CV
Full  1.03812  0.94382 – 1.14184  0.13587
EMA   1.03812  0.95463 – 1.12890  0.11238
  Analysis of response2 (period effects):
  Model    PE         90% CI          CV
Full  1.04055  0.94932 – 1.14054  0.13087
EMA   1.04055  0.95834 – 1.12980  0.11030