EMA - Exclusion of data [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2012-01-24 17:47 (5253 d 00:02 ago) – Posting: # 7997
Views: 3,650

Dear d_labes,

❝ -Is this also applicable for AUC(0-tau) in multiple dose studies?

I don't see why not.

❝ -What is the geometric mean in replicate cross-over studies? Overall or calculated for each replicate?

They mean lsmeans or model effects, I hope. Pick the one that fits. "Geometric mean" is a term that should be banned. Employees using that term could with some fairness be sentenced to 200 years of hard labour in the salt mines.

❝ -What to do in case of crossover design with more than one Reference?

Compare just the pairwise relevant treatments (yeah yeah, I know).

❝ -Should an algorithm implemented recursively (i.e. repeated after exclusion of identified outlier with respect to the 5% criterion in a first run)? Any opinion out there?

Does it makes any difference with realistic data??

❝ -Why do people buy music by the Bee Gees?

I honestly never really understood that myself. Good question.

Best regards,
EM.

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