title: The process of evaluating and regulating a new drug: phases of a drug study.
abstract: Nearly every aspect of anesthesia care involves a strong working knowledge of the pharmacodynamics and pharmacokinetics of a vast number of drugs. Several times each year, anesthesia providers are challenged with the introduction of a drug new to the market. Most healthcare providers understand that before a new drug can be used to treat patients, it must be put through meticulous clinical trials that are stringently regulated. These clinical trials are the most expensive and most vital part in the process of new drug development, as the establishment of safety and efficacy is paramount. The purpose of this article is to review the process every new drug must go through before it can be marketed in the United States, from the chemist's bench to the pharmacist's shelf (or anesthetist's cart!), and the primary institution and laws that govern this process.
authors.affiliation: Mercy Hospital South of the Carolinas Medical Center-Pineville in Charlotte, NC, USA.
authors.forename: Christine C
authors.initials: CC
authors.lastname: Cowan
mesh_terms: D000818:Animals; D017277:Drug Approval / Q000379:methods*; D004341:Drug Evaluation / Q000331:legislation & jurisprudence* / Q000379:methods*; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D014481:United States