This page outlines the drug testing process, which starts with testing numerous chemicals on lab animals and may lead to human trials through an IND application to the FDA. The human trials consist of...This page outlines the drug testing process, which starts with testing numerous chemicals on lab animals and may lead to human trials through an IND application to the FDA. The human trials consist of three phases: Phase I focuses on safety in healthy volunteers, Phase II tests efficacy and side effects in patients, and Phase III collects comprehensive safety and effectiveness data. Upon successful completion, a NDA is submitted, and the drug is branded for market release.
