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临床试验是新药研究过程中的重要环节之一,也是考察新药疗效是否确切安全和有否发展前途的关键。本文结合我省新药临床研究的情况,着重从管理角度对新药临床研究几个主要问题加以讨论。一、临床试验的主要任务和基本原则新药试验的主要任务是通过对人体的药效学、药代动力学的研究以确定新药的疗效和适应症;摸索用法和剂量;观察新药的毒、副反应并寻找防治对策等。临床试验新药工作中应遵守“确保安全,明确标准,设立对照,正确评价”几项基本原则。(1)确保受试者的安全
Clinical trials are one of the important links in the research of new drugs. They are also the key to examine whether the efficacy of new drugs is safe and has a promising future. In this paper, the clinical research of new drug in our province, focusing on the management of the new drug clinical research to discuss several major issues. First, the main tasks of clinical trials and basic principles The main task of new drug testing is through the human pharmacodynamics, pharmacokinetic studies to determine the efficacy of new drugs and indications; to explore usage and dosage; observation of new drug toxicity, vice Response and look for prevention and treatment measures. Clinical trials of new drugs should comply with the “ensure safety, clear standards, establish a control, correct evaluation ” a few basic principles. (1) to ensure the safety of the subjects