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posted by Helmut Homepage – Vienna, Austria, 2013-05-22 22:54 (4765 d 12:56 ago) – Posting: # 10621
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Hi Ken!

❝ […] how elimination rate constant (ke) and elimination half-life (t1/2) are analyzed statistically ? Same as for AUC ??


Nobody requires a comparison. Elimination is drug-specific (i.e., does not depend on the formulation). Just report the means ± SD (geometric – or harmonic, if you want to split hairs).

❝ What about Tmax ? As Tmax is analyzed statistically using non-parametric test for 2-way crossover design (2x2), I presumed this parameter should also be analyzed the same way for fully replicate design (2x4). The only difference is taking the average of Tmax of test and reference product.


Wait until the draft will be finalized: No statistical comparison required any more. ;-)

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