Approximately 30% of drugs have failed in human clinical trials due to adverse reactions despite promising pre-clinical studies, and another 60% fail due to lack of efficacy. One of the major causes in the high attrition rate is the poor predictive value of current preclinical models used in drug development despite promising pre-clinical studies in 2-D cell culture and animal models. Microphysiological Systems or Tissue Chips are bioengineered microfluidic cell culture systems seeded with primary or stem cells that mimic the histoarchitecture, mechanics and physiological response of functional units of organs and organ systems. These platforms are useful tools for predictive toxicology and efficacy assessments of candidate therapeutics. Implementation of tissue chips in drug development requires effective partnerships with stakeholders, such as regulatory agencies, pharmaceutical companies, patient groups, and other government agencies. Tissue chips are also finding utility in studies in precision medicine, environmental exposures, reproduction and development, infectious diseases, microbiome and countermeasures agents.

中文翻译：

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NIH微生理系统程序：开发用于开发药物安全性和有效性的体外工具。

尽管有前途的临床前研究，但由于不良反应，约有30％的药物在人类临床试验中失败，而由于缺乏疗效，还有60％的药物失败。尽管在二维细胞培养和动物模型中进行了有希望的临床前研究，但高流失率的主要原因之一是目前用于药物开发的临床前模型的预测价值差。微生理系统或组织芯片是生物工程化的微流体细胞培养系统，接种有原代或干细胞，可模拟器官和器官系统功能单元的组织结构，力学和生理反应。这些平台是用于候选疗法的预测毒理学和功效评估的有用工具。在药物开发中实施组织芯片需要与利益相关者建立有效的伙伴关系，例如监管机构，制药公司，患者团体和其他政府机构。组织芯片还可以用于精密医学，环境暴露，生殖和发育，传染病，微生物组和对策制剂的研究中。