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Register3 arm study [Design Issues]
Dear Ms.Bharathi,
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.
❝ 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
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
Complete thread:
- 3 arm study bharathi 2012-03-01 13:07
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 3 arm studydrgunasakaran1 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 studydrgunasakaran1 2012-03-01 16:46
Ing. Helmut Schütz