The need for pharmacokinetics protocols in special cases.
The need for pharmacokinetics protocols in special cases.
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特殊情况下需要药代动力学方案。
DOI：
10.1006/phrs.1993.1002
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发表时间：
1993
影响因子：
9.3
通讯作者：
M. Calvi
中科院分区：
文献类型：
--
作者：
M. Regazzi;R. Rondanelli;M. Calvi
欧洲共同体指令中的“长期使用药物临床实验要求”标题下确认了药代动力学方案对于特殊患者群体的重要性。根据这些指南，参与这些试验的患者必须……“尽可能代表未来将接受相关药物治疗的人群”[1, 2]。特殊患者群体的临床药代动力学方案的基本目的是确定在这些群体中测试的药物的药代动力学行为是否与其他患者的药代动力学行为大致相同。因此，应该强调的是，测量的药代动力学参数的重要性主要在于它们与先前在“正常”人群中获得的结果的比较。
The importance of pharmacokinetics protocols for special groups of patients is confirmed in the European Community directives under the heading “Requirements For The Clinical Experimentation of Drugs Designed for Long-Term Use”. According to these guidelines the patients who participate in these trials must be...“as representative as possible of the population who will be treated in the future with the drug in question”[1, 2]. The fundamental aim of clinical pharmacokinetics protocols in special groups of patients is to determine whether the pharmacokinetic behavior of the drug being tested on these groups will prove to be more or less the same as that in other patients. Therefore it should be stressed that the importance of the pharmacokinetic parameters measured lies mainly in their comparison with the results previously obtained in the “normal” population.