Phase I

Phase I Phase I research studies involve the first time the investigational medication has been introduced in humans. Known as "safety studies", the purpose of Phase I research is to observe the medication's action in a small number of humans while assessing potential side effects as the dosage is increased. Participants are very closely monitored since patient safety is a high priority.

The majority of Phase I studies require overnight stays in special facilities complete with patient rooms, dining accommodations, recreational areas, and 24-hour medical staffing. Phase I studies provide pharmaceutical companies the essential information to determine the medication's safety as well as the appropriate dosage range. Once medication safety and dosage range has been established, pharmaceutical companies expand testing into Phase II studies.