Bioequivalence and Bioavailability Forum • Biosimilars

Biosimilars [Design Issues]

posted by drgunasakaran1 – 2012-02-06 14:57 (4453 d 00:37 ago) – Posting: # 8059
Views: 4,972

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

Dear Mr.Vasu,

You can enroll healthy volunteers in the Pharmacokinetic studies required for Biosimilars like Interferon alpha See section 5 Clinical Studies (Page 5 of 7).

Efficacy and safety studies of Biosimilars will be done in patient population.

Kindly go through EMA's Product Specific Biosimilar Guidances.

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]

—
Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.

Complete thread:

Biosimilars M.Vasu 2011-11-24 14:01 [Design Issues]
- 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
    - Biosimilarsdrgunasakaran1 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