EMA: New product-specific guidances [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2022-04-08 17:17 (293 d 20:54 ago) – Posting: # 22918
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Dear all,

on April 04 the EMA published revised draft product-specific guidances for ibuprofen, paracetamol, and tadalafil. In the footnote on page 1 we find:

* This revision concerns defining what is meant by ‘comparable’ Tmax as an additional main pharmacokinetic vari­able in the bioequivalence assessment section of the guideline.

Then:

Bioequivalence assessment: Comparable median (≤ 20% difference) and range for Tmax.


See this article why I consider this invention crap.
In short: tmax follows a discrete distribution on an ordinal scale. Calculating the ratio of values is a questionable procedure (strictly speaking not an allowed operation at all: Only addition, subtraction, ranking are).

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