Ligand Binding Assay Critical Reagents and Their Stability: Recommendations and Best Practices from the Global Bioanalysis Consortium Harmonization Team
Author:
Publisher
Springer Science and Business Media LLC
Subject
Pharmaceutical Science
Link
http://link.springer.com/content/pdf/10.1208/s12248-014-9583-x.pdf
Reference32 articles.
1. DeSilva B, Smith W, Weiner R, Kelley M, Smolec J, Lee B, et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm Res. 2003;20(11):1885–900.
2. Mire-Sluis AR, Barrett YC, Devanarayan V, Koren E, Liu H, Maia M, et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J Immunol Methods. 2004;289(1–2):1–16.
3. Nowatzke W, Woolf E. Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samples. AAPS J. 2007;9(2):E117–22.
4. Rup B, O’Hara D. Critical ligand binding reagent preparation/selection: when specificity depends on reagents. AAPS J. 2007;9(1):E148–55.
5. Staack RF, Stracke JO, Stubenrauch K, Vogel R, Schleypen J, Papadimitriou A. Quality requirements for critical assay reagents used in bioanalysis of therapeutic proteins: what bioanalysts should know about their reagents. Bioanalysis. 2011;3(5):523–34. doi: 10.4155/bio.11.16 .
Cited by 61 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献
1. Long term investigation of formulation buffers to mitigate stability issues of conjugated critical reagents;Journal of Immunological Methods;2024-10
2. A comprehensive LC–MS based study of factors influencing biotinylation of critical reagents;Bioanalysis;2024-09-04
3. Neutralizing Antibody Sample Testing and Report Harmonization;The AAPS Journal;2024-07-12
4. Immunocapture LC–MS Methods for Pharmacokinetics of Large Molecule Drugs;Bioanalysis;2024-02-13
5. A Case Study for Critical Reagent Qualification for Ligand Binding Assays Using Equivalence Test Methodology;The AAPS Journal;2023-09-15
1.学者识别学者识别
2.学术分析学术分析
3.人才评估人才评估
"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370
www.globalauthorid.com
TOP
Copyright © 2019-2024 北京同舟云网络信息技术有限公司 京公网安备11010802033243号 京ICP备18003416号-3