Bioequivalence and Bioavailability Forum

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

posted by Helmut  – Vienna, Austria, 2022-04-08 17:17 (293 d 20:54 ago) – Posting: # 22918
Views: 2,837

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’ T_max as an additional main pharmacokinetic vari­able in the bioequivalence assessment section of the guideline.

Then:

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

See this article why I consider this invention crap.
In short: t_max 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).

End of consultation 31 July 2022.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• EMA: New product-specific guidancesHelmut 2022-04-08 15:17 [BE/BA News] 
  • How would you implement it? ElMaestro 2022-04-09 11:45
    • Confuse a Cat Inc. Helmut 2022-04-09 18:40
      • Confuse a Cat Inc. ElMaestro 2022-04-09 21:47
        • Confuse a Cat Inc. Ohlbe 2022-04-11 11:29
          • Confuse a Cat Inc. Helmut 2022-04-11 13:59
            • Range Ohlbe 2022-04-11 15:48
              • Range Helmut 2022-04-11 16:07
                • Range Ohlbe 2022-04-11 16:20
              • Range Helmut 2022-07-28 14:43
        • So many questions, so few answers Helmut 2022-04-11 13:03
        • Preliminary simulations Helmut 2022-04-30 14:59
          • Preliminary simulations ElMaestro 2022-04-30 19:10
            • Preliminary simulations Helmut 2022-05-01 15:56
        • Simulated distributions Helmut 2022-05-02 13:43