Johns Hopkins University, Bloomberg School of Public Health, CAAT, Baltimore, MD 21205, USA.
ALTEX. 2012;29(3):251-60. doi: 10.14573/altex.2012.3.251.
The desire to develop and evaluate drugs as potential countermeasures for biological and chemical threats requires test systems that can also substitute for the clinical trials normally crucial for drug development. Animal models have limited predictivity for drug efficacy, as is well known from many disappointments in clinical trials. Traditional in vitro and in silico approaches are not really game changers here, but the substantial investment into novel tools now underway might bring about a second generation of alternative approaches. The avenue pursued focuses primarily on the development of a Human on a Chip, i.e., the combination of different three-dimensional (stem) cell-based organ equivalents combined with microfluidics. The prospects of such approaches, their impact on the field of alternative approaches, and necessary complementary activities are discussed. The need to adapt quality assurance measures and experiences from validation is stressed.
开发和评估潜在的生物和化学威胁药物的愿望需要测试系统，这些系统也可以替代药物开发通常至关重要的临床试验。众所周知，动物模型对药物疗效的预测性有限，临床试验中有许多失败的例子。传统的体外和计算机模拟方法在这里并不是真正的改变游戏规则的方法，但现在正在进行的对新工具的大量投资可能会带来第二代替代方法。所追求的途径主要集中在开发人体芯片上，即不同的三维（干细胞）基于器官的等效物与微流控技术的结合。讨论了这些方法的前景、它们对替代方法领域的影响以及必要的补充活动。强调了需要适应质量保证措施和验证经验。
