创新性药物非临床安全性评价的基本要点.pdfVIP

C h in e se Jou rna l o f N ew D rug s 20 10, 19 (24 ) ( 国家食品药品监督管理局药品审评中心, 北京 100038) [] 创新性药物是以治疗临床疾病满足患 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 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 的安全为风险目标作为技术审评 , 应该 以保护患 利益满足患 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 和上市后患 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 [] 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 [] R95 [] C [] 1003 3734( 2010) 24 2261 06 Basic p rincip les for nonclin ical safety evaluation of the novel drug PENG Jian (C enter f or D rug Evaluation, S tate F ood and D rug A dm in istration, B eij ing 100038, Ch ina ) [ Abstract] The novel drug includes the new chem icals or biotechnologyderived pharmaceuticals w ith the new clinical values. They have been driven by mi proving the currently available medical treatment andmeeting the unmet clinical need. Nonclinical safety evaluation is one of the prmi ary factors of controlling the safety risk to sub jects in clinical trails by integrated with clinical trail protocols. The main goal is to protect the patient benefits and to m eet the clinical needs in comply w ith ethicalprinciple. The value of nonclinical safety is to support the conduct of related clinical trai.l For the strategy of nonclinical safety study ( content and tmi ing), study design and result a nalysis for each drug, researchers should consider nature of indications, clinical needs, the stage of clinical devel opment 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 nonclinica