Bioequivalence and Bioavailability Forum

Main page Policy Latest Posts Abbreviations

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

posted by ElMaestro – Denmark, 2021-08-23 16:42 (521 d 13:56 ago) – Posting: # 22532
Views: 2,874

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 [BE/BA News]
- 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
22,477 posts in 4,708 threads, 1,603 registered users;
17 visitors (0 registered, 17 guests [including 7 identified bots]).
Forum time: 05:39 CET (Europe/Vienna)

In these matters the only certainty is
that nothing is certain. Pliny the Elder

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz