新药临床前药效学评价的体会（Experience of preclinical pharmacodynamic evaluation of new drugs）.doc

新药临床前药效学评价的体会（Experience of preclinical pharmacodynamic evaluation of new drugs） Experience in preclinical pharmacodynamic evaluation Update: 2009-11-23: click on the month, Yang Sujuan, Tao Laibao, Fu Yanrong, Tan Hongling Abstract: the paper discusses the preclinical efficacy of ten new drug evaluation work. Discuss the experience and establish corresponding experimental model and experimental methods of the experience and problems. Keywords: new drug evaluation; disease models, animal; evaluation index; screening method CLC number: R965 document code: B article number: 1003-9783 (1999) 03-0 136-02 In the past ten years, my room was more than a dozen preclinical pharmacodynamic evaluation, including traditional Chinese medicine, western medicine and biological preparations. Accumulated experience, we established the experimental model and the corresponding methods, there are also some problems and ideas discussed as follows. 1 and animal model The animal health is the most basic conditions for the completion of preclinical pharmacodynamic evaluation, unhealthy animal will appear all sorts of abnormal reaction caused by false negative and positive results. In addition, animal and race is a difference between man and animal in pharmacodynamics, toxicology and pharmacokinetics are differences in response to drug substance and quantity. Therefore, preclinical pharmacodynamic evaluation should be based on the characteristics of drug action as much as possible and the homology of a large animal, and as far as possible to choose several animal in animal species selection. At present the main problems are low, the qualified rate of some animal species is little, or no animal, such as commonly used abroad in cynomolgus monkeys, rats only Wistar strains, choose the category which limited the pharmacodynamics evaluation. The establishment of a variety of new drug evaluation model for us, the main effect of a new drug in different species and different methods by the model. B