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3D Cell Culture: Protection for the Achilles Heel of Active Substance Research?

机译:3D细胞培养:对活性物质研究的跟腱的保护?

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On 19 March 2006, the German newspaper 'Frankfurter Allgemeine Zeitung' described drug tests for clinical Phase I studies as the "Achilles heel of drug development". In this phase, the active substance is administered to a small group of healthy test candidates in concentrations below the therapeutic dose. The clinical trial is preceded by the preclinical test phase, in the final stage of which the active substance is tested in mammals. After the successful completion of the preclinical phase, approximately 10% of all active substances fail due to unexpected side effects in humans. These unexpected side effects can have serious consequences for the test participants. What solution strategies exist in order to reduce such "adverse effects"? 3D cell culture provides promising approaches in order to improve the research of the method of effect of drug candidates. Against the background that essential approval procedures are internationally harmonised, the results of the different 3D cultivation approaches should be intercomparable. From the ranks of the various suppliers, a standard system for 3D culture which best fulfils the requirements of the pharmaceutical industry could become established in the near future.
机译:2006年3月19日,德国报纸《法兰克福汇报》(Frankfurter Allgemeine Zeitung)将用于临床I期研究的药物测试描述为“药物开发的致命弱点”。在该阶段,将活性物质以低于治疗剂量的浓度给予一小群健康的候选测试对象。临床试验之前是临床前试验阶段,在该阶段的最后阶段是在哺乳动物中测试活性物质。在成功完成临床前阶段后,所有活性物质中约有10%因人体意外副作用而失效。这些意外的副作用可能会对测试参与者造成严重后果。为了减少这种“不利影响”,存在哪些解决方案策略? 3D细胞培养提供了有前途的方法,以改善对候选药物作用方法的研究。在基本批准程序在国际上得到统一的背景下,不同3D培养方法的结果应该是可比的。从各个供应商的队伍中,可以在不久的将来建立最能满足制药行业要求的3D文化标准系统。

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