3 arm study [Design Issues]
Dear All,
First, I need to thank - Mr.Helmut's plan for having such a great forum and for all the members who responds/replies queries
We are planning to do a 3 arm study.
Investigational products - 2 test products and a reference product
Difference between test products -
Final weight of the tablet (1 being 1.1 gm and other 700 mg)
Similarity of test products -
1) Same excipients are used (only difference being the quantities)
2) In-vitro performance (Dissolution profiles of both products are exactly matching with the innovator) which gives us the confidence to go further
Pilot study for 1 test product was performed and results were satisfactory.
Please can anyone here suggest whether I am thinking in the right direction..
Regards,
Bharathi
Edit: Category changed. [Helmut]
First, I need to thank - Mr.Helmut's plan for having such a great forum and for all the members who responds/replies queries
We are planning to do a 3 arm study.
Investigational products - 2 test products and a reference product
Difference between test products -
Final weight of the tablet (1 being 1.1 gm and other 700 mg)
Similarity of test products -
1) Same excipients are used (only difference being the quantities)
2) In-vitro performance (Dissolution profiles of both products are exactly matching with the innovator) which gives us the confidence to go further
Pilot study for 1 test product was performed and results were satisfactory.
Please can anyone here suggest whether I am thinking in the right direction..
Regards,
Bharathi
Edit: Category changed. [Helmut]
Complete thread:
- 3 arm studybharathi 2012-03-01 13:07
- 3 arm study drgunasakaran1 2012-03-01 16:46
- 3 arm study kaushik089 2012-03-02 08:03
- 3 arm study Vardhan82 2012-03-02 13:32
- 3 arm study drgunasakaran1 2012-03-01 16:46
