Bioequivalence and Bioavailability Forum • Biosimilars

Biosimilars [Design Issues]

posted by Helmut – Vienna, Austria, 2011-11-24 15:44 (5320 d 00:52 ago) – Posting: # 7714
Views: 9,272

Dear VM,

many countries have issued detailed guidelines already. The most comprehensive ones are EMA’s. See the Guidance page and scroll down to

○ Biotechnological and Biological Products, Biosimilars

Although GLs consider cross-over studies the ‘Gold Standard’ in all (!) studies I have personally seen (and know of from other people as well) a significant sequence effect was observed. Maybe a parallel design is the better option.

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

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Complete thread:

Biosimilars M.Vasu 2011-11-24 14:01
- BiosimilarsHelmut 2011-11-24 14:44
  - Biosimilars M.Vasu 2011-11-28 12:33
    - Healthy subjects vs. patients Helmut 2011-11-28 12:56
    - Biosimilars drgunasakaran1 2012-02-06 13:57
  - Biosimilars Ben 2011-12-16 19:04
- Biosimilars Chiku 2012-02-03 06:43
  - Biosimilars drgunasakaran1 2012-02-10 11:33
    - Biosimilars Chiku 2012-02-10 12:03
      - Biosimilars Kumarnaidu2 2021-10-22 07:53