Abstract
Phase I studies constitute the foundation upon which the entire drug development program must be built. A properly conducted Phase I program should define the dose range, potential side effects, duration of action, and route of excretion for the drug under study. Most importantly, it should define the human pharmacology of the drug.
The regulations governing Phase I trials have developed in response to public concerns and catastrophic events. Current legislation reflects and defines the roles and relationships of the sponsor, the investigator, the institution, and the volunteer.
Future Phase I activities will be greatly influenced by the globalization of the pharmaceutical industry and the need for science-based, rather than regulatory-based, studies.
Get full access to this article
View all access options for this article.