Bioequivalence and Bioavailability Forum • model-based BE?

model-based BE? [BE/BA News]

posted by mittyri – Russia, 2022-12-07 17:26 (897 d 03:36 ago) – Posting: # 23389
Views: 9,714

Hi Helmut and All!

regarding

FDA encourages generic and new drug applicants to propose and discuss novel methodologies (e.g., model-based BE…)

(lines 56-58)

are you reading this as a projection of VBE or some broader successful trends exist?

—
Kind regards,
Mittyri

Complete thread:

New guidance on Statistical Approaches to Establishing Bioequivalence Relaxation 2022-12-02 15:53 [BE/BA News]
- 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- Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence SMA 2023-02-06 09:07
  - Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Achievwin 2023-02-07 07:13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

Admin contact
23,424 posts in 4,927 threads, 1,680 registered users;
53 visitors (0 registered, 53 guests [including 14 identified bots]).
Forum time: 22:03 CEST (Europe/Vienna)

Being really good at C++ is like being really good
at using rocks to sharpen sticks. Thant Tessman

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz