Bioequivalence and Bioavailability Forum • Healthy subjects vs. patients

Healthy subjects vs. patients [Design Issues]

posted by Helmut – Vienna, Austria, 2011-11-28 13:56 (4531 d 09:38 ago) – Posting: # 7741
Views: 5,598

Dear VM!

❝ […] kindly explain me can i enroll healthy subjects for biosimilars BA/BE study ?

In the EU biosimilars are solely registered centrally at EMA. This process includes submission of protocols and generally scientific advisory meetings… You are aware that you need to perform phase III studies in the patient population to demonstrate safety/efficacy? When it comes to BE, healthy volunteers should be OK – providing safety/efficacy are not an issue. If possible include PD endpoints in the PK studies. See also the recent concept paper.

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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. patientsHelmut 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