How are drugs approved? Part 3. The stages of drug development.
The first article of this series on the drug development process described the historical evolution of the U.S. Food and Drug Administration (FDA), and last month's article reviewed the ethical foundations of clinical research. Before a new drug is marketed, a sequence of preclinical investigations and three phases of clinical studies are conducted. This drug development process involves the FDA, pharmaceutical companies (sponsors), clinical investigators, and institutional review boards. This article further describes this aspect of the drug development process.
Howland
Robert H
RH
University of Pittsburgh, School of Medicine, Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania 15213, USA. HowlandRH@upmc.edu
D002986:Clinical Trials as Topic; D017277:Drug Approval / Q000458:organization & administration*; D004353:Drug Evaluation, Preclinical; D006801:Humans; D009937:Organizational Objectives; D017751:Safety Management / Q000458:organization & administration; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration