Bioequivalence and Bioavailability Forum • 3 arm study

3 arm study [Design Issues]

posted by Vardhan82 – India, 2012-03-02 14:32 (5228 d 18:05 ago) – Posting: # 8204
Views: 3,271

Dear Ms.Bharathi,

❝ 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)

Why you are planning to conduct BE study with two test products? Are you planning to register two test formulations as generics?

❝ 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

It seems difference in quantity of excipients, may not have significant effect on release of the drug substance from formulation.

❝ 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..

Yes, your thinking is correct, but to be on safe side you can compare the dissolution profile of new test Vs pilot test formulation in discriminative media to get more confidence...

Thanks,
Vardhan

Edit: Standard quotes restored. [Helmut]

Complete thread:

3 arm study bharathi 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 studyVardhan82 2012-03-02 13:32