摘要
本文目的是简要介绍新药临床试验的特点和新药Ⅰ至Ⅳ期临床试验设计之要览。新药Ⅰ期临床试验的受试对象是健康志愿者,其研究的主要内容是新药的耐受性和药代动力学;新药Ⅱ期临床试验的受试对象是与药物有对应适应证的患者,其研究的主要内容是探索合适的用药剂量,评价药物的疗效和安全性;新药Ⅲ期临床试验的受试对象是与药物有对应适应证的患者,其研究的主要内容是在更大的样本含量前提下,进一步评价药物的疗效和安全性;新药Ⅳ期临床试验的受试对象是与药物有对应适应证的患者,其研究的主要内容是在新药上市后且在开放和大样本条件下扩大受试者人群,进一步发现前期临床试验的偏差,探讨和发现药物的远期疗效和罕见的不良反应,为临床合理用药提供依据。
This article aimed to briefly introduce the characteristics and overview for the design of the phase I to IV clinical trials of a new drug. The subjects in the phase I clinical trial of a new drug are healthy volunteers and the main contents of the research are the tolerance and pharmacokinetics of a new drug. The subjects in the phase II clinical trial of a new drug are the patients with the corresponding indications for the drug. The main contents of the research is to explore the appropriate dose, evaluate the efficacy and safety of a new drug. The subjects in the phase IH and IV clinical trials of a new drug are also the patients with the corresponding indications for the drug. The main contents of the phase IH and IV clinical trials are to further evaluate the efficacy and safety of a new drug, meanwhile to discover the deviation of the pre - clinical trials which helps to explore and find the long - term efficacy of drugs as well as rare adverse reactions, respectively. Additionally, the phase IV clinical trial provided the basis for the rational use of a new drug by enlarging the range of the subjects after the new drug applied in the market in an open form.
出处
《四川精神卫生》
2017年第4期310-316,共7页
Sichuan Mental Health
基金
国家高技术研究发展计划课题资助(2015AA020102)
关键词
临床试验
耐受性
药代动力学
药效动力学
不良反应
纳入标准
排除标准
Clinical trial
Tolerance
Pharmacokinetics
Pharmacodynamics
Adverse reactions
Inclusion criteria
Exclusion criteria
