Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Clin Pharmacol Ther. 2014 May;95(5):478-80. doi: 10.1038/clpt.2014.46.
Assessment of controllable sources of intra- and interpatient variability in drug response is of critical importance in the regulatory evaluation of new drugs.(1) Although determinants of response variability would ideally be understood and accounted for before approval of a new pharmaceutical product, this is rarely the case for all; clinical trials in specific populations that definitively test optimal dosing in patient management strategies are not routinely performed prior to drug approval.
评估药物反应中个体内和个体间可控制的变异源对于新药物的监管评估至关重要。(1) 尽管在批准一种新的药物产品之前，理想情况下应该了解并考虑到反应变异性的决定因素，但并非所有因素都如此；在药物批准之前，通常不会在特定人群中进行临床试验来明确测试患者管理策略中的最佳剂量。
