Bioequivalence and Bioavailability Forum • Biosimilars

Biosimilars [Design Issues]

posted by Ben – 2011-12-16 20:04 (4513 d 04:35 ago) – Posting: # 7784
Views: 5,240

Dear Helmut/all,

you wrote

❝ 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.

Is there a specific reason why this is so? I mean, this sounds like the problem of having a sequence effect always occurs when having biosimilars. What is so "special" about them causing sequence (or carryover or trt*prd interaction) effects?

Thanks,
Ben

Complete thread:

Biosimilars M.Vasu 2011-11-24 14:01
- Biosimilars Helmut 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
  - BiosimilarsBen 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