Assay Formats: Recommendation for Best Practices and Harmonization 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/s12248-013-9552-9.pdf
Reference27 articles.
1. Myler HA, Given A, Kolz K, Mora JR, Hristopoulos G. Biotherapeutic bioanalysis: a multi-indication case study review. Bioanalysis. 2011;3(6):623–43 [Review].
2. US Department of Health and Human Services, Food and Drug administration, CDER, CVM. Guidance for Industry, Bioanalytical Method Validation, 2001.
3. 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 [Guideline].
4. Fast DM, Kelley M, Viswanathan CT, O’Shaughnessy J, King SP, Chaudhary A, et al. Workshop report and follow-up–AAPS Workshop on current topics in GLP bioanalysis: assay reproducibility for incurred samples—implications of Crystal City recommendations. AAPS J. 2009;11(2):238–41 [Review].
5. Smolec J, DeSilva B, Smith W, Weiner R, Kelly M, Lee B, et al. Bioanalytical method validation for macromolecules in support of pharmacokinetic studies. Pharm Res. 2005;22(9):1425–31 [Review Validation Studies].
Cited by 36 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. A generic anti-drug antibody assay for monoclonal antibody therapeutics with broad dynamic range eliminates the need for titer evaluation in preclinical studies;Journal of Pharmaceutical and Biomedical Analysis;2024-10
2. Development of time‐resolved fluoroimmunoassay with enhanced fluorescence reaction for the quantitation of atezolizumab in plasma;Luminescence;2024-05
3. Automated Bioanalytical Workflow for Ligand Binding-Based Pharmacokinetic Assay Development;Analytical Chemistry;2023-12-29
4. Novel highly sensitive chemiluminescence immunoassay for quantitation of durvalumab using a signal enhanced horseradish peroxidase-luminol-hydrogen peroxide reaction for detection system;Talanta Open;2023-08
5. RETRACTED: Development of a highly sensitive chemiluminescence immunoassay using a novel signal-enhanced detection system for quantitation of durvalumab, an immune-checkpoint inhibitor monoclonal antibody used for immunotherapy of lung cancer;Heliyon;2023-06
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