摘要
非临床药理毒理研究贯穿于整个药物研发过程,药理毒理审评的重点在于全面把控风险未知的候选药物用于人体时的安全有效性,并通过动物试验获得部分临床试验无法获取的安全性信息。通过解析同一个候选药申请不同适应症的临床试验典型案例,诠释以临床为核心,基于临床试验方案,case by case的评估临床风险获益的药理毒理审评理念,旨在帮助读者了解药理毒理评价思路,指导研发者对药物研发过程中的药理毒理问题进行有效评估,提高药品研发效率。
The non-clinical pharmacology and toxicology research goes throughout the entire process of drug development. The main objects of pharmacological and toxicological evaluation are to clarify the safety and effective features of a new drug candidate with unknown risks before applied to human, and to collect some safety information in animal studies which cannot be carried out in human. This article has elaborated the review logics of the non-clinical pharmacology and toxicology such as concentrating on clinical studies, based on clinical protocols comprehensively reviewing of the risk-benefits ratio via analyzing of a drug candidate applying for different indications. This article is intended to help readers of understanding the logics behind the non-clinical pharmacology and toxicology review and direct researchers to effectively evaluate the pharmacology and toxicology issues in RD and improve the efficiency of drug development.
作者
尹华静
胡晓敏
王庆利
余珊珊
YIN Huajing;HU Xiaomin;WANG Qingli;YU Shanshan(Center for Drug Evaluation,China Food and Drug Administration,Beijing 100022,China)
出处
《药物评价研究》
CAS
2018年第9期1565-1569,共5页
Drug Evaluation Research
关键词
非临床评价
药理毒理
安全性
生殖毒性
ICH
M3(R2)
Non-clinical Evaluation
pharmacology and toxicology
safety
reproductive toxicity
ICH M3（R2）
