When preclinical trial steps have led to a new investigational drug, introduction in human subjects is the next step. The company begins clinical trials in order to test the effects of the drug in target populations. Depending on the results of initial trials, regulatory authorities may require additional clinical testing in order to rule out any dangerous side effects or to prove that the benefits of the drug outweigh the potential risks. Large, multi-center trials have become the norm in today's regulatory environment. Results from the clinical trials are then compiled and submitted to the regulatory authorities, along with all preclinical data, in a new drug application (NDA). For detailed information on the regulatory submission and approval process, see Chapter 6.
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