The introduction of new drugs into anaesthetic practice: a perspective in pharmaceutical development and regulation.

摘要: This article reviews the process by which new drugs are introduced into anaesthetic practice with particular emphasis on pharmaceutical development and government regulation. After a brief overview of drug process, trends in discussed including implementation pharmacokinetic, pharmacodynamic toxicokinetic studies both preclinical human phases evaluation. A synopsis regulatory is provided and, particular, problem unapproved use anaesthesia discussed. Ethical issues regarding physician-industry interactions highlighted examples conflict interest anaesthesia. The processes regulation require much effort cooperation between clinicians, manufacturers regulators to achieve common goal; utilization safe effective drugs. fundamental understanding these may farther facilitate optimal active involvement anaesthetists process.