Biosimilars [Design Issues]
❝ […] kindly explain me can i enroll healthy subjects for biosimilars BA/BE study ?
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.
- Biosimilars M.Vasu 2011-11-24 14:01 [Design Issues]
- Biosimilars Helmut 2011-11-24 14:44
- Biosimilars Chiku 2012-02-03 06:43