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But that tiny big difference suggests exploration on Program I medicines requires a handful of excess hoops that investigate on other medications don’t. The first step is usually to pen a protocol for just a examine: a prepare for the way the researchers intend to perform their investigation.
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This protocol is judged by an institutional evaluate board, an impartial team that testimonials any clinical trials involving people. If a review requires a Plan I drug, when the board approves the protocol as moral, the scientists must make an application for an investigational new drug (IND) number from your FDA.