Bioequivalence and Bioavailability Forum • Bioequivalence study?

Bioequivalence study? [Design Issues]

posted by Helmut – Vienna, Austria, 2016-05-03 13:55 (3246 d 02:09 ago) – Posting: # 16267
Views: 8,961

Hi Pravin,

I know one European assessor who rejects protocols containing the word bioequivalence in its title. Yes, even if it is a study of IR vs. IR.

Homework: Why does he do so?
Bonus question: Why is he right?

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Complete thread:

Reg-Bio Availability or Bio Equivalence study pravin17 2016-05-03 08:07 [Design Issues]
- Bio Availability or Bio Equivalence study Ohlbe 2016-05-03 10:25
  - Bio Availability or Bio Equivalence study jag009 2016-05-09 23:09
    - Different rates = BE if intentional (FDA def.) Helmut 2016-05-10 16:08
      - Different rates = BE if intentional (FDA def.) Ohlbe 2016-05-10 22:03
- Bio Availability or Bio Equivalence study nobody 2016-05-03 10:41
- Bioequivalence study?Helmut 2016-05-03 11:55
  - Bioequivalence study? nobody 2016-05-03 14:07
  - Bioequivalence study d_labes 2016-05-03 15:50
    - Bioequivalence study Helmut 2016-05-03 17:44
      - Investigation of ... d_labes 2016-05-04 08:43