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一个新药,从发现,经评价,到正式投产上市,要经过多种学科协同研究.这种研究,既有同一时期各学科的横向联系,也有不同时期工作的纵向发展.这样,就需要把这些工作科学地组织起来.新药评价组织工作的目的就是将各学科工作科学地组织起来以提高评价工作的质量,缩短研究周期,提供有效而安全的新药,保障人民健康.在具体着手组织新药评价的研究工作时,有三个基本要素需要掌握.这就是学科基础、工作程序和指挥协调.下面分别讨论一下这三方面的工作.一、学科基础要进行新药评价工作就必需有相当水平
A new drug, from discovery, evaluation, to the official launch of the market, is subject to a variety of disciplinary collaborative research .This kind of research, both the same period of horizontal contact between disciplines, but also the longitudinal development of different periods of work.Thus, we need to put these Work scientifically organized.New drug evaluation organization is designed to scientifically organize the work of various disciplines in order to improve the quality of evaluation work, shorten the research cycle and provide effective and safe new drugs to protect people’s health.In the specific organization of the evaluation of new drugs Research work, there are three basic elements need to master.This is the basis of the discipline, work procedures and command and coordination.The following are the three aspects of the work to be discussed.A discipline base to carry out the evaluation of new drugs must have a considerable level