创新性药物非临床安全性评价的基本要点  

Basic principles for nonclinical safety evaluation of the novel drug

作　　者：彭健[1] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国新药杂志》2010年第24期2261-2266,共6页Chinese Journal of New Drugs

摘　　要：创新性药物是以治疗临床疾病、满足患者临床需求为导向而研发的新化合物实体或新生物技术药物。药物的非临床安全性评价是药物进入首次人体临床试验、临床开发过程中结合临床试验方案控制受试者安全性风险的重要过程。非临床安全性研究的地位和价值是通过分阶段支持临床试验这一最终目的得以实现。任何药物的非临床安全性研究策略(项目和时间安排)、试验设计和结果评价等基本要点都应在把握药物研发一般规律基础上依据适应症性质、临床开发阶段或临床试验方案、药物特点、法规及技术指导原则要求等综合考虑,并以支持其临床试验方案合理控制受试者的安全为风险目标。作为技术审评者,应该以保护患者利益、满足患者临床需求的伦理学原则为最高标准,并以科学、法规和技术要求为手段,把握好临床试验受试者和上市后患者用药安全性风险控制的宏观管理策略和非临床安全性审评的技术标准。The novel drug includes the new chemicals or biotechnology-derived pharmaceuticals with the new clinical values.They have been driven by improving the currently available medical treatment and meeting the unmet clinical need.Nonclinical safety evaluation is one of the primary factors of controlling the safety risk to subjects in clinical trails by integrated with clinical trail protocols.The main goal is to protect the patient benefits and to meet the clinical needs in comply with ethical principle.The value of nonclinical safety is to support the conduct of related clinical trail.For the strategy of nonclinical safety study（content and timing）,study design and result analysis for each drug,researchers should consider nature of indications,clinical needs,the stage of clinical development and study protocols,characteristics of pharmaceuticals and requirement of regulation and guidance,real condition and clinical practice in China.Thus,it should be sure that the objective for nonclinical is met,and safety risk to the subject is reasonably controlled.As a technical reviewer,the ethical principle for protecting subject benefits in clinical studies and patients in clinical practice is the priority of standards to conduct nonclinical evaluation of novel drugs,by using the science and regulatory requirements as supporting standards.

关 键 词：创新性药物 非临床安全性评价 研究策略 试验设计 结果评价 

分 类 号：R95[医药卫生—药学]