Nordic Bioscience A/S, Herlev, Denmark.
Biomarkers. 2010 May;15(3):195-204. doi: 10.3109/13547500903434519.
The success in biomedical sciences such as genomics and proteomics is not paralleled in the medical product development methods. The consequence of this is a lack of translation into improved drug safety and efficacy. Therefore the US Food and Drug Administration (FDA) introduced the Critical Path Initiative in 2004 to modernize drug development and safety pharmacology. Bone is that largest tissue by weight, and is continuously remodelled. Changes in bone turnover lead to complications such as osteoporosis and fracture, that is associated with an increased mortality. Recent findings have identified bone as a possible endocrine organ and the availability of valid biochemical bone markers suggests that assessing bone turnover should also play an important role in general safety pharmacology.
在生物医学科学（如基因组学和蛋白质组学）方面的成功并没有在医疗产品开发方法中得到体现。其结果是药物安全性和疗效没有得到改善。因此，美国食品和药物管理局（FDA）于 2004 年推出了关键路径倡议，以实现药物开发和安全药理学的现代化。骨骼是人体中重量最大的组织，并且在不断重塑。骨转换的变化会导致骨质疏松症和骨折等并发症，这与死亡率的增加有关。最近的研究结果表明，骨骼可能是一种内分泌器官，有效的生化骨标志物的出现表明，评估骨转换也应该在一般安全药理学中发挥重要作用。
