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新药评价过程中有种种管理工作.诸如课题计划管理、经费管理、实验室工作质量管理(GLP)、药品生产质量管理(GMP)、新药宣传(说明书、广告)管理等都是很重要的管理工作,都与保证新药研究的质量,保证新药使用的安全与有效密切有关.在各种管理工作中有一项比较重要的管理,那就是新药人体试用的管理.新药必须经过临床评价才能肯定它的疗效和毒付作用.动物实验做得再多,也不能完全预测人体的反应.因此,从根本上来说,新药总是在它的毒付作用还不十分清楚的情况下试用于人体的,因而就总带有一定的冒险性,总要担一点风险.不担一点风
There are various management tasks in the evaluation of new drugs, such as project planning management, fund management, laboratory work quality management (GLP), pharmaceutical manufacturing quality management (GMP), new drug promotion (manuals, advertising) management are all important management tasks , All are closely related to ensuring the quality of new drug research and ensuring the safe and effective use of new drugs.An important management in various management work is the management of new drug human trial.New medicine must undergo clinical evaluation to confirm its efficacy And drug-poisoning.Animal experiments have done more and can not completely predict the body’s response.Therefore, fundamentally, the new drug is always applied to the human body when its drug-poisoning effect is not yet clear enough Always with a certain risk, always bear a little risk