Good question! [Nonparametrics]

posted by Helmut Homepage – Vienna, Austria, 2012-01-17 12:34 (4160 d 04:03 ago) – Posting: # 7954
Views: 12,252

Dear Joshua!

❝ Can anyone kindly guide on how to do the non-parametric analysis for tmax for a two treatment, three period, three sequence (partial replicate) design.

Good point. Since tmax is not required for the FDA, I guess you are referring to the EMA’s GL?

A statistical evaluation of tmax is not required. However, if rapid release is claimed to be clinically relevant and of importance for onset of action or is related to adverse events, there should be no apparent difference in median tmax and its variability between test and reference product.

The EMA hates nonparametrics – which is manifested in the first sentence. ‘No apparent difference in median tmax without statistics boils down to :blahblah: in the discussion section of the report. How can we assess the variabilities? I would go with reporting the products’ IQRs followed by :blahblah:. In a partial replicate I would mean the two administrations of the reference.

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