Phase I trials

Definition

Phase I trials are conducted to provide initial indications about the safety of therapeutic interventions and, in the case of drugs, their pharmacodynamic and, pharmacokinetic properties. They involve a small number of subjects (typically 20 to 100), who are often healthy volunteers. In some areas, such as oncology, however, they may involve patients with the disease intended to be treated by the intervention, and so can also provide initial indications of therapeutic activity.

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