Healthy subjects vs. patients [Design Issues]
Dear VM!
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.
❝ […] 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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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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 M.Vasu 2011-11-28 12:33
- 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
- Biosimilars Chiku 2012-02-10 12:03
- Biosimilars drgunasakaran1 2012-02-10 11:33
- Biosimilars Helmut 2011-11-24 14:44