疾病模型动物在非临床安全性评价中应用的探讨

摘要

The current drug non-clinical safety evalua-tion has been highly systematized and standardized, but the standard toxicology model is still some inade-quacies, need to consider other animal models of safety evaluation. This paper will expound the need of animal disease models using in safety evaluation from the as-pect of scientific theories, data requirements and the need of clinical. Then recognizing on the perspective of drug regulatory agencies to explore the feasibility of u-sing animal disease models for safety evaluation and the deficiencies, in order to predict as accurately as possi-ble of the adverse drug reactions in clinical, applied to reduce the risk of clinical patients ( patients benefit ) , and reduce the risk of drug development failures ( pharmaceutical companies benefit ) . All in all we should attach great importance to the applications of animal disease models in non-clinical safety evalua-tion.%当前药物非临床安全性评价已高度系统化和标准化，但标准毒理学模型仍存在不足之处，需要考虑采用其他动物模型进行安全性评价。该文从科学理论、数据需求以及临床需要方面阐述了采用疾病模型动物进行安全性评价的必要性，同时从药品监管机构的认识角度探讨了使用疾病模型动物进行安全性评价的可行性、不足之处，为了尽可能准确地预测药物在临床上的不良反应，降低临床应用于患者的风险(患者获益)，降低药品研发失败的风险(制药企业获益)，研究者应该高度重视疾病模型动物在非临床安全性评价中应用。