Drug or medical device ? [Design Issues]

posted by raghavendra_s – 2010-02-02 06:38 (5993 d 06:56 ago) – Posting: # 4691
Views: 3,121

Dear Helmut and Ohlbe,

Thank you very much for valuable information.

As it is an intra-articular injection for Osteoarthritis. Probably in India, it would be Drug.

Being it a local injection, how one can go ahead with design of a study which involves a three arm study viz. Placebo, Reference and Test.

A information is higly aprreciated,

Thanks in advance,

Kind regards

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