新药引进初评的量化探讨

目的:建立新药引进初评的量化评分办法。方法:根据制药厂或医药公司资质、“医保”分类、中标情况、同品种对比、药效学与药动学参数、专科用药及临床需求等,设计量化评分项目与内容,赋予分值,当总分达到预定分值,即可进入下一程序,否则不予引进。结果与结论:通过量化评分,可科学、客观地对新药进行评估,减少新药引进的盲目性和随意性。

Discussion on Quantitative Preliminary Evaluation of Introduced New Drugs

OBJECTIVE: To establish a quantitative preliminary evaluation of introduced drugs. METHODS: A quantitative form was designed for new drugs’ preliminary evaluation, which included many factors, such as qualification of pharmaceutical factory or company, category of drugs in medical insurance, the result of the biding drugs, comparison with other drugs of the same category, PK and PD data,special use and clinical demand. Each factor was given a definite score .If the total scores of a given drug amounted to the expected figure, this drug could pass the preliminary evaluation and enter the next step, and if not, the drug may be eliminated. RESULTS&CONCLUSION: The purpose of evaluating the new drugs scientifically and objectively can be basically achieved through quantitative method, which can lessen the blindness in introduction of new drugs.