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Pre-Clinical Development

Healthcare and Medical

Pre-clinical development is the stage of drug or medical device development that occurs before human clinical trials, involving laboratory and animal studies to assess safety, toxicity, and biological activity. Pharmaceutical scientists and researchers use this phase to gather the data required to file an Investigational New Drug (IND) application with regulators like the FDA. It is a critical gatekeeping step that determines whether a candidate therapy is safe enough to test in humans.

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