Investigate the application of animal disease models in non-clinical safety evaluation
10.3969/j.issn.1001-1978.2014.10.027
- VernacularTitle:疾病模型动物在非临床安全性评价中应用的探讨
- Author:
Keyong NING
;
Wei YANG
- Publication Type:Journal Article
- Keywords:
animal disease models;
non-clinical;
safety evaluation;
untoward effect;
drug evaluation;
drug discovery
- From:
Chinese Pharmacological Bulletin
2014;(10):1462-1463,1464
- CountryChina
- Language:Chinese
-
Abstract:
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.
