Bioanalytical method validation for macromolecules in support of pharmacokinetic studies.
Bioanalytical method validation for macromolecules in support of pharmacokinetic studies.
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DOI：
10.1007/s11095-005-5917-9
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发表时间：
2005-09-01
影响因子：
3.7
通讯作者：
Karnes, H Thomas
中科院分区：
文献类型：
--
作者：
Smolec, JoMarie;DeSilva, Binodh;Karnes, H Thomas
近年来，用于支持药代动力学研究的配体结合试验的开发和验证一直是各种研讨会和出版物的重点，所有这些都是为了建立这些生物分析方法标准化的指导文件。这份2003年研讨会的简要报告侧重于发言中讨论的问题，并说明了与会者的讨论要点和共识领域。
The development and validation of ligand binding assays used in the support of pharmacokinetic studies has been the focus of various workshops and publications in recent years, all in an effort to establish a guidance document for standardization of these bioanalytical methods. This summary report of the workshop from 2003 focuses on the issues discussed in presentations and notes points of discussion and areas of consensus among the participants.