The first administration of a new active substance to humans

Abstract

The first administration of a new chemical or biological substance to humans may be conducted in a Phase I unit of a pharmaceutical company or contract research organisation (CRO) or in a hospital by an academic investigator. There has been an expansion of all such activities in recent years and the whole Phase I area has been put on a much more professional footing. To some extent the setting depends on whether the volunteers are healthy or patients since patients are generally more accessible in hospitals whilst CROs tend to use healthy volunteers. Whatever the setting and the nature of the volunteers, there are special considerations which pertain to all such studies. The same considerations are relevant to many studies performed at an early stage of a drug’s development not only to the first administration.