Drug development, clinical trials, and regulatory requirements

Abstract The drug development process as we know it today did not exist before the second half of the 20th century. Over the past several decades, regulatory agencies have been developed to monitor drug development and ensure that novel therapeutic agents are safe for human use and effective for their desired indications. The rigour and requirements with which drugs are studied and clinical trials are performed have evolved with decades of slowly expanding guidelines and regulations. After identifying a target for therapeutic intervention, drugs undergo a series of preclinical investigations in animal models. If deemed to be of potential value to humans, drugs are then tested in a series of three phases of clinical trials to evaluate their optimal dosing in humans, feasibility, generalizability, as well as their safety and efficacy. Once approved by regulatory bodies, drugs may eventually be marketed to the public. Post-marketing, drugs continue to be monitored lifelong for development of any short-term and long-term adverse events via phase IV surveillance.