Identity, Strength, Purity, Quality, and Safety: Common Goals for New Drugs

Abstract

There are different arrangements by which a radiopharmaceutical can be studied in humans. The metabolim and pharmacology of derivatives of approved drugs can be studied under the mechanism of the Research Drug Research Committee (RDRC). The procedures, safeguards and safety issues are reviewed and approved by an institutional committee, which in turn is answerable to regulatory agencies. For studies involving efficacy for either diagnostic or therapeutic clinical application, an Investigational New Drug exemption must be requested. Details of manufacture, testing, and safety must be submitted to US FDA in a formal application. Such an IND study may be sponsored by a company intending to commercialize a product or by physicians studying a disease state. Before the product may be sold or distributed, a New Drug Application (NDA) must be filed and approved by the FDA. Once approved, the radiopharmaceutical can be routinely prescribed in clinical practice.