Bioequivalence and Bioavailability Forum • WHO: scaling for AUC?

WHO: scaling for AUC? [BE/BA News]

posted by Ohlbe – France, 2017-06-12 15:29 (2889 d 23:35 ago) – Posting: # 17488
Views: 14,216

Dear all,

The WHO is apparently opening a pilot phase to allow scaling for AUC on a case-by-case basis. Protocols and justifications are to be submitted in advance to the WHO PQP team.

—
Regards
Ohlbe

Complete thread:

WHO: scaling for AUC?Ohlbe 2017-06-12 13:29
- 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