Using "innovative drug" R & D chain as background,this chapter aim to analyze the risks in the different stages of new drugs development and the strategies that can cope with in corporate management.The life cycle of new drug R & D projects can be divided into four phases:(1) early screening of drugs,including the creation and optimization of lead compounds,in vitro and in vivo pharmacodynamic efficacy model model,the market potential evaluation; (2) pre-clinical studies,including pharmacology,toxicology,pharmacy and microbiology studies,etc.; (3) clinical trials,including safety,efficacy,pharmacokinetics studies,etc.; (4) listing and marketing control.The causes of the risk of new drug R & D projects are complex and analysis are needed for each of these new drug R & D process in each stage,in order to look for any uncertain factors that may be encountered in that stage,as well as the probability of these factors,and the degree of influence on the R & D projects.Strategies are adopted to enhance the effective control of risk,thereby reducing the transfer and dispersion of the risk of new drug R & D projects to improve the success rate of new drug R & D projects and enhance the competitiveness of pharmaceutical companies.
专门的词不会翻,参考了翻译软件给出的英文.最后一句「新药研发项目风险……企业的竞争力」太长,分开来说比较清楚.
希望能够帮助你!