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bharathi ☆ India, 2012-03-01 14:07 (5233 d 13:28 ago) Posting: # 8198 Views: 3,944 |
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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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drgunasakaran1 ★★  2012-03-01 17:46 (5233 d 09:49 ago) @ bharathi Posting: # 8201 Views: 3,310 |
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Dear Ms.Bharathi, ❝ Pilot study for 1 test product was performed and results were satisfactory. You can go for pivotal if the pilot results were satisfactory. Why are you planning to do a three arm study.? Are you planning to see the PK profile of the second formulation and tries to see, if it matches better with the innovator than your first formulation. If this is the case, you can go for 3 arm study. Kindly accept my apologies, if I understood your query wrongly. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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kaushik089 ★ India, 2012-03-02 09:03 (5232 d 18:32 ago) @ drgunasakaran1 Posting: # 8203 Views: 3,251 |
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hello, Dr.gunasakaran sir , can i know the purpose of 3 arm studies thank u, kaushik |
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Vardhan82 ☆ India, 2012-03-02 14:32 (5232 d 13:03 ago) @ bharathi Posting: # 8204 Views: 3,298 |
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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] |
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