Persiani Stefano, Larger Patrice
Department of Drug Metabolism, Pharmacokinetics and Dynamics, Rottapharm spa, Via Valosa di Sopra, 7, 20052 Monza, MI, Italy.
Expert Opin Drug Metab Toxicol. 2006 Oct;2(5):675-86. doi: 10.1517/17425255.2.5.675.
Translational medicine is the drug development phase in which preclinical and clinical applied research is conducted to aid dose and disease selection with great financial impact. Thus, during this phase, early discontinuation of a drug that will later fail due to drug interactions is a must for a proper resource allocation. It is not only important to identify a potential interaction, but also to be able to differentiate between detectable interactions and clinically relevant interactions. Due to the scientific advancement, the prediction of drug interactions during translational medicine has shifted from empirical/observational to rational based. These investigations are thus in line with the FDA's Critical Path Initiative and are facilitated by the availability of mature technologies and by current European and US guidelines for both in vitro and in vivo studies. Because drug interactions must be evaluated in a multidisciplinary fashion, even if these studies are contracted externally, pharmaceutical companies should be directly involved in the conduction of such studies to fully exploit their potential and to allow a better and faster interpretation of the results.
转化医学是药物研发阶段，在此阶段进行临床前和临床应用研究，以辅助剂量和疾病选择，具有重大财务影响。因此，在此阶段，对于因药物相互作用而后期会失败的药物，尽早停用是合理分配资源的必要条件。识别潜在的相互作用不仅很重要，而且能够区分可检测到的相互作用和临床相关的相互作用也很重要。由于科学进步，转化医学中药物相互作用的预测已从经验性/观察性转向基于理性的预测。因此，这些研究符合美国食品药品监督管理局（FDA）的关键路径倡议，并且由于成熟技术的可用性以及当前欧洲和美国关于体外和体内研究的指南而得到促进。由于必须以多学科方式评估药物相互作用，即使这些研究是外包的，制药公司也应直接参与此类研究的开展，以充分发挥其潜力，并能更好、更快地解读结果。
