A phase 1 clinical trial includes the initial introduction of an investigational new drug product, including biological drug products, into humans. Such studies are conducted to establish the basic safety of the drug, and are designed to determine the metabolism and pharmacologic actions of the drug in humans. The total number of subjects in a phase 1 clinical trial is limited generally to no more than 80 subjects.
This presentation covers the CGMP’s for Investigation New Drugs for Phase I. The presentation has been compiled from publicly available material on the world wide web by “ Drug Regulations” a not for profit organization.