Utilizing Clinical Research Organizations for late Phase I studies
A key step in developing a new drug is the transition from the laboratory to the human subject in a Phase I clinical trial, where the new compound is given to humans for the first time. A Phase I trial is the gateway between scientific research and clinical medicine. Generally, in-human Phase I studies are conducted in healthy male patients or healthy male volunteers; however later Phase I-Ib trials are conducted in-human with the affected disease the compound is intended to treat.Phase I studie...
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