To obtain approval from the Food and Drug Administration (FDA) or an equivalent agency outside the United States to market and sell a new drug or biologic product for use in humans, a series of clinical studies must be performed. These clinical studies exist in four phases. Each phase has specific and differing requirements for patient types, goals, inclusion/exclusion criteria, design features, and expected outcomes. Combined, they build the patient care database for safety and efficacy that hopefully will lead to product approval.
ASJC Scopus subject areas
- Agricultural and Biological Sciences(all)