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 (1148 d 18:34 ago) – Posting: # 22532
Views: 4,511

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

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