非臨床藥理毒理研究貫穿于整個藥物研發(fā)過程，藥理毒理審評的重點(diǎn)在于全面把控風(fēng)險(xiǎn)未知的候選藥物用于人體時的安全有效性，并通過動物試驗(yàn)獲得部分臨床試驗(yàn)無法獲取的安全性信息。通過解析同一個候選藥申請不同適應(yīng)癥的臨床試驗(yàn)典型案例，詮釋以臨床為核心，基于臨床試驗(yàn)方案，case by case的評估臨床風(fēng)險(xiǎn)獲益的藥理毒理審評理念，旨在幫助讀者了解藥理毒理評價(jià)思路，指導(dǎo)研發(fā)者對藥物研發(fā)過程中的藥理毒理問題進(jìn)行有效評估，提高藥品研發(fā)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 R&D and improve the efficiency of drug development.