Some school math [Software]

posted by d_labes  – Berlin, Germany, 2012-04-27 17:21 (5168 d 00:38 ago) – Posting: # 8467
Views: 5,342

Dear AB,

Sorry but none is correct :no:. If you have transformed your PK metric (AUC or Cmax) logarithmically, as the Progesterone guidance recommends, the ESTIMATE statement in the step "Intermediate analysis - ilat" gives you the difference estimate=log(µT)-log(µR). Recalling your school math you will obtain the point estimator back-transformed to the original values by

exp(estimate) = exp(log(µT)-log(µR)) = exp(log(µT))/exp(log(µR)) = µT/µR.

To cite the guidance:
"From the dataset IGLM2, calculate the following:
IGLM2: pointest=exp(estimate);
      ...
"

The ratio µT/µR is sometimes called geometric mean ratio (GMR). But this is only an approximately valid statement.
See for that

Hauschke, Steinijans, Pigeot
"Bioequivalence Studies in Drug Development"
Wiley, Chichester (2007)
Chapter 3.2.2 "The lognormal distribution"


Ouch! Helmut has outpaced my post :cool:.
Full ACK with his statement concerning ASAP.

Regards,

Detlew

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