Bioequivalence and Bioavailability Forum • WHO: scaling for AUC confirmed

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

posted by Ohlbe – France, 2021-07-02 12:31 (1025 d 20:08 ago) – Posting: # 22451
Views: 3,374

Dear all,

This is no longer a pilot phase: see here. A priori approval is no longer required, but pre-submission of the protocol for comments remains strongly recommended.

—
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 confirmedOhlbe 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