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目的探讨影响化学药物技术评价的几个关键因素,促进化学药物技术评价体系的科学构建。方法从药品行政审批、药物研发、药物应用等方面与技术评价的关系入手,结合我国现状进行剖析。结果明确了化学药物技术评价体系与药品行政审批、药物研发和药物应用之间的关系与相互作用。结论化学药物技术评价贯穿于化学药物的整个生命周期,只有将评价工作与药物监管等多个方面有机结合,才能对药物进行准确评价并确保公众用药安全。
Objective To explore several key factors influencing the evaluation of chemical drugs and to promote the scientific construction of the evaluation system of chemical drugs. Methods Starting with the relationship between drug administrative examination and approval, drug research and development, drug application and technical evaluation, the paper analyzes the current situation in our country. The results clearly defined the relationship and interaction between the evaluation system of chemical drugs and the approval of drug administration, drug development and drug application. Conclusion The evaluation of chemical drug technology runs through the entire life cycle of chemical drugs. Only by integrating the evaluation work and drug regulation and other aspects can the accurate evaluation of drugs be conducted and the safety of public use of drugs ensured.