Bioequivalence and Bioavailability Forum • FDA guideline on BE, draft August 2021

FDA guideline on BE, draft August 2021 [BE/BA News]

posted by ElMaestro – Denmark, 2021-08-23 16:42 (1356 d 22:16 ago) – Posting: # 22532
Views: 5,489

Hi all,

looks like FDA updated the canonical BE guideline for ANDAs. Draft. :-)

:-)

—
Pass or fail!
ElMaestro

Complete thread:

FDA guideline on BE, draft August 2021ElMaestro 2021-08-23 14:42
- FDA guideline on BE, draft August 2021 Helmut 2021-08-23 15:31
  - FDA guideline on BE, draft August 2021 Achievwin 2021-09-08 04:09
    - Bias correction unveiled Helmut 2021-09-10 20:47
- FDA guideline on BE, draft August 2021 Achievwin 2021-08-23 21:35
  - FDA guideline on BE, draft August 2021 Helmut 2021-08-23 23:46

Admin contact
23,424 posts in 4,927 threads, 1,669 registered users;
114 visitors (0 registered, 114 guests [including 5 identified bots]).
Forum time: 14:59 CEST (Europe/Vienna)

Lack of clarity is always a sign of dishonesty. Celia Green

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz