Bioequivalence and Bioavailability Forum • model-based BE?

model-based BE? [BE/BA News]

posted by SMA – Europe, 2023-01-17 10:41 (138 d 13:30 ago) – Posting: # 23425
Views: 2,222

Dear all

❝ • EMA does not exclude use of model informed BE, especially in cases when in vivo BE studies cannot be simply conducted in healthy subjects.

❝ • When model-based BE is used, model evaluation should include technical and clinical validation of the model as well as assessment of its applicability.

Please note this interesting and very recent publication by some European regulators (incl members of MWP), which IMHO does not contain solutions yet, but establishes the principle that there is some openness to discuss this topic with EMA:

Manolis, E, García-Arieta, A, Lindahl, A, Kotzagiorgis, E, Limberg, J, Holte, Ø, Paixao, P, Versantvoort, C, Tshinanu, FM, Blake, K, Van Den Heuvel, M. Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective. CPT: pharmacometrics & systems pharmacology. 2023-Jan-11. Link

Complete thread:

New guidance on Statistical Approaches to Establishing Bioequivalence Relaxation 2022-12-02 15:53
- A first look Helmut 2022-12-02 16:43
  - A first look jag009 2022-12-02 17:58
    - A first look BRB 2022-12-02 18:20
  - SAS strikes back mittyri 2022-12-02 20:38
    - SAS strikes back Helmut 2022-12-02 22:30
      - Outliers? mittyri 2022-12-02 22:52
        
        Outliers? Helmut 2022-12-02 23:11
      - SAS strikes back Achievwin 2023-02-07 07:23
  - model-based BE? mittyri 2022-12-07 16:26
    - model-based BE? Helmut 2022-12-10 10:13
      - Hooker, Moellenhoff et al. are moving MBBE forward mittyri 2023-01-11 15:32
      - model-based BE?SMA 2023-01-17 09:41
  - A first look PharmCat 2022-12-21 19:30
  - A first look Rayhope 2023-01-06 06:56
- Groups, sites… Helmut 2022-12-03 13:09
- SxF ElMaestro 2022-12-04 06:34
  - SxF Helmut 2022-12-10 10:37
- New guidance on Statistical Approaches to Establishing Bioequivalence Mahmoud 2022-12-10 14:08
- Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence SMA 2023-02-06 09:07
  - Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Achievwin 2023-02-07 07:13
    - Multi-group studies ad nauseam Helmut 2023-02-07 11:30
      - Multi-group studies ad nauseam Achievwin 2023-02-25 16:18
    - Webinar: Recording available Helmut 2023-04-01 10:38
  - Speed kills Helmut 2023-02-07 13:02