DeSimone Danielle, Shih Judy Y, Gunn Han C, Patel Vimal, Uy Lennie, Thway Theingi M
Department of Pharmacokinetic & Drug Metabolism, Amgen Inc., Thousand Oaks, CA 91320, USA.
Bioanalysis. 2011 Sep;3(18):2143-52. doi: 10.4155/bio.11.199.
To support clinical trials, bioanalytical methods are often transferred from one laboratory to another. With the rising number of large-molecule therapeutic proteins submitted for US FDA approval, the demand for large-molecule bioanalytical support and, subsequently, method transfer increases. Ligand-binding assays are the methods most commonly used to quantify endogenous and therapeutic proteins for the assessment of biomarkers and pharmacokinetic parameters. The goal of this review is to provide an overview of ligand-binding assay method transfer, essential parameters for partial method validation and to lay out a strategy to increase the chance of success. The recommendations herein are based on a summary of current publications and the authors' specific experiences, to help increase workload efficiency, maintain positive collaborations with partners and meet program timelines.
为支持临床试验，生物分析方法常常需要在不同实验室之间进行转移。随着提交给美国食品药品监督管理局（US FDA）批准的大分子治疗性蛋白质数量不断增加，对大分子生物分析支持以及随之而来的方法转移的需求也在增加。配体结合测定法是最常用于定量内源性和治疗性蛋白质以评估生物标志物和药代动力学参数的方法。本综述的目的是概述配体结合测定法的方法转移、部分方法验证的关键参数，并制定提高成功几率的策略。本文中的建议基于当前出版物的总结以及作者的具体经验，以帮助提高工作效率、与合作伙伴保持积极合作并满足项目时间表。
