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

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The drug discovery processbegins with the identification ofa 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 thesehypotheses, specific objectives will be set for the project.

Then, testingselected chemicalsin appropriatebiological testscan begin. Key subsequent steps in the process include detecting relevant biological activity (a 'hit') for a structurally novel compoundin vitro, then finding a related compound withinvivoactivityin an appropriateanimal 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 undergoestoxicological testing in animals, as required by law.

If the compound passes all these tests, all the accumulated research data are assembled and submitted as anInvestigational New Drug Application (IND)to theFood and Drug Administration (FDA)in the United States (or comparable agency in other countries) beforeclinical trialsare 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 bywidespread trials【Phase III】in thousands of appropriate patients to develop a broad database ofefficacy and safety. For the few (4–7%) drug candidates thatsurvivethis series of development trials, aNew Drug Application (NDA)that contains all the accumulated research data is filed for thorough review by the experts at theFDA. Only with their approval can the new drug be offered todoctorsand 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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