3 arm study [Design Issues]

posted by bharathi – India, 2012-03-01 14:07 (5232 d 05:01 ago) – Posting: # 8198
Views: 3,931

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]

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