Browne T R
Department of Neurology, Boston University School of Medicine, Massachusetts, USA.
J Clin Pharmacol. 1998 Mar;38(3):213-20. doi: 10.1002/j.1552-4604.1998.tb04418.x.
Stable isotope labeled (SIL) drug methods are compared with standard methods for performing early (phases I and IIa) drug development studies (mass balance, bioavailability, single-dose volunteer and patient, multiple-dose volunteer and patient). SIL methods offer considerable reduction in the cost (> 50%) and number of subjects (67%) required for bioavailability and multiple-dose patient studies. Moreover, a complete early drug development program is described for optimally combining SIL and standard studies, which can reduce cost by 23% and number of subjects by 36% compared with a program using standard methods. These reductions should result in development time savings of at least one year.
将稳定同位素标记（SIL）药物方法与用于进行早期（I期和IIa期）药物开发研究（质量平衡、生物利用度、单剂量志愿者和患者、多剂量志愿者和患者）的标准方法进行了比较。SIL方法可显著降低生物利用度和多剂量患者研究所需的成本（>50%）和受试者数量（67%）。此外，还描述了一个完整的早期药物开发计划，用于优化SIL和标准研究的结合，与使用标准方法的计划相比，该计划可将成本降低23%，受试者数量减少36%。这些减少应能节省至少一年的开发时间。
