Pharmacokinetic/pharmacodynamic modelling in oncological drug development
Pharmacokinetic/pharmacodynamic modelling in oncological drug development
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DOI：
10.1111/j.1742-7843.2005.pto960310.x
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发表时间：
2005-03-01
影响因子：
3.1
通讯作者：
Xie, RJ
中科院分区：
文献类型：
--
作者：
Karlsson, MO;Anehall, T;Xie, RJ
对于许多肿瘤药物来说，骨髓抑制是剂量限制性毒性，药物剂量、血浆浓度和血液学毒性之间关系的定量表征在药物开发中具有重要意义。为此目的，开发了基于机制的群体药代动力学-药效模型，并回顾了这些模型在候选药物选择、首次人体研究、前药和制剂开发、剂量发现、方案优化、评估修饰剂的影响、药物组合研究、亚组识别和反馈个体化方面的应用。
For many oncological agents, myelosuppression is the dose-limiting toxicity and the quantitative characterisation of the relationship between drug dose, plasma concentration and haematological toxicity is of importance in the drug development. Mechanism-based population pharmacokinetic-pharmacodynamic models have been developed for this purpose and the applications of these in candidate selection, first-in-man studies, prodrug and formulation development, dose finding, schedule optimisation, assessing influence of modifying agents, drug combination studies, subgroup identification and feedback individualisation are reviewed.