药物研发过程流程图

上一篇 / 下一篇  2010-11-05 16:04:35/ 个人分类:新药研发


The drug discovery process begins with the identification of a medical need, including a judgement on the adequacy of existing therapies (if there are any). From this analysis, together with an appraisal of the current knowledge about the target disease, will come hypotheses on how to possibly improve therapy — that is, what efficacy, safety or mechanistically novel improvements will advance the method of drug treatment for patients with the target disease? On the basis of these hypotheses, specific objectives will be set for the project.

Then, testing selected chemicals in appropriate biological tests can begin. Key subsequent steps in the process include detecting relevant biological activity (a 'hit') for a structurally novel compound in vitro, then finding a related compound with in vivo activity in an appropriate animal model, followed by maximizing this activity through the preparation of analogous structures, and finally selecting one compound as the drug development candidate. This drug candidate then undergoes toxicological testing in animals, as required by law.

If the compound passes all these tests, all the accumulated research data are assembled and submitted as an Investigational New Drug Application (IND) to the Food and Drug Administration (FDA) in the United States (or comparable agency in other countries) before clinical trials are initiated. In the clinic, there is sequential evaluation in normal human volunteers of toleration (Phase I), efficacy and dose range in patients (Phase II), followed by widespread trials【Phase III】 in thousands of appropriate patients to develop a broad database of efficacy and safety. For the few (4–7%) drug candidates that survive this series of development trials, a New Drug Application (NDA) that contains all the accumulated research data is filed for thorough review by the experts at the FDA. Only with their approval can the new drug be offered to doctors and their patients to treat the disease for which it was designed.

【原文链接:http://www.nature.com/nrd/journal/v3/n10/full/nrd1523.html

注:费城的美中药协曾经组织过2次有关药物研发全过程的会议。 【1】 由在药物研发流水线上的各个专家讲解自己那个部分的工作,从生物靶体的发现一直到最后的商业化,深受听众的欢迎。后来部分人员回国讲过几次,也受到好评。 后来协会的很多成员提议大家以后再搞一次,不过由于这几年的海归浪潮汹涌澎湃,怕是要重新组建队伍了。

参考

【1】美中药协的药物研发全过程会议议程:会议内容01  会议内容02   

TAG: 药物研发

 

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