Drug Development for New Psychiatric Drug Therapies.

Abstract

Drug development is an expensive, high risk, and highly regulated process. Only about 6.2% of new molecules tested for mental disorders eventually achieve Food and Drug Administration (FDA) approval. New molecular entities are produced, and extensive in vitro animal testing is performed before they are evaluated in humans. The compound is used in animals to predict clinical effects in humans, and studies addressing pharmacodynamics, pharmacokinetics, toxicology, and mutagenicity are conducted. Human research proceeds in three stages with the ultimate goal of proving that a new agent is efficacious and safe for a treatment of a specific disease in humans. If efficacy and safety are demonstrated in two Phase III studies, then the sponsor can submit a new drug application (NDA) to the FDA. The FDA oversees each step of the process to assure that good research practices are followed, data integrity is assured, and human research subjects are protected.