Bioequivalence and Bioavailability Forum • WHO: Chapeau!

WHO: Chapeau! [BE/BA News]

posted by Helmut – Vienna, Austria, 2019-06-10 11:23 (1081 d 09:19 ago) – Posting: # 20322
Views: 4,871

Hi ElMaestro,

» » Obviously people at the WHO are more clever than the EMA’s

Update 22 November 2018:

As of November 2018, PQTm will accept the use of scaling of the AUC acceptance criteria for data from a full 4-period replicate design study for products containing albendazole or mebendazole. It is not necessary to provide a scientific justification a priori as described below for albendazole or mebendazole.

Only those two? No other HVD(P)s in the list of essential drugs? Or no studies submitted in the pilot phase since June 2017?

» They specifically seem to want to compare variability for Ref and Test.

Still no information how that should be done.

Like in the days of PBE/IBE
- ‘Similar’ variability was concluded if \(0.667\leq s_{wT}/s_{wR}\leq1.500\).
Like in the FDA’s warfarin guidance
- Variabilities are considered ‘comparable’ if the upper confidence limit of \(\sigma_{wT}/\sigma_{wR}\leq2.5\).

—
Dif-tor heh smusma 🖖
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Complete thread:

WHO: scaling for AUC? Ohlbe 2017-06-12 13:29 [BE/BA News]
- WHO: Chapeau! Helmut 2017-06-12 23:31
  - WHO: Chapeau! ElMaestro 2017-06-13 00:08
    - WHO: Chapeau! nobody 2017-06-13 09:28
    - WHO: Chapeau!Helmut 2019-06-10 11:23
      - WHO: Chapeau! ElMaestro 2019-06-11 18:51
- WHO: scaling for AUC confirmed Ohlbe 2021-07-02 10:31
  - No comparison of variabilities any more 😀 Helmut 2021-07-02 15:11
  - WHO: scaling for AUC confirmed kratos 2021-08-03 10:38
    - EMA: scaling for AUC = utopia Helmut 2021-08-03 12:54