Table 2 FDA clinical study phases for new drug applications
“The new drug application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale in the United States” [17] | |
|---|---|
Phase 1 | Emphasizes the assessment of safety - how a new drug is metabolized and excreted, how a drug should be given, how often, at what dose. It is usually conducted with a small number of healthy volunteers. |
Phase 2 | Continues to test safety and begins to evaluate how well a drug works by comparing it with a different treatment, usually a placebo or another drug. Conducted in a larger sample. |
Phase 3 | Tests the efficacy of a new drug in comparison to the current standard, evaluates dosages and overall risk-benefit of the drug. Conducted in a large numbers of volunteers. |
Phase 4 | Studies post-approval use of a drug if the FDA judges the need to gather population data on drug safety. |