THE INTRODUCTION OF NEW DRUGS INTO ANESTHETIC PRACTICE - A PERSPECTIVE IN PHARMACEUTICAL DEVELOPMENT AND REGULATION

被引：4
作者：
GILRON, I
机构：
[1] Department of Anaesthesia, McGill University, Montreal, H3A 1A1, Quebec
来源：
CANADIAN JOURNAL OF ANAESTHESIA-JOURNAL CANADIEN D ANESTHESIE | 1995年 / 42卷 / 06期
关键词：
DRUG REGULATION; DRUG INDUSTRY; ANESTHETICS; CLINICAL PHARMACOLOGY;
D O I：
10.1007/BF03011691
中图分类号：
R614 [麻醉学];
学科分类号：
100217 ;
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 the drug development process, new trends in drug development are discussed including implementation of pharmacokinetic, pharmacodynamic and toxicokinetic studies in both preclinical and human phases of drug evaluation. A synopsis of the drug regulatory process is provided and, in particular the problem of unapproved drug use in anaesthesia is discussed Ethical issuer regarding physician-industry interactions are highlighted by examples of conflict of interest in anaesthesia. The processes of drug development and regulation require much effort and cooperation between clinicians, pharmaceutical manufacturers and government regulators to achieve a common goal; the development and utilization of safe and effective drugs. A fundamental understanding of these processes may further facilitate optimal drug utilization and the active involvement of anaesthetists in the drug development process.
引用
收藏
页码：516 / 522
页数：7
相关论文
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