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lgli/Xiaohui (Sophia) Xu, Weifeng Xu - Bioanalytical Aspects in Biological Therapeutics (2022, Wiley).pdf
Bioanalytical Aspects in Biological Therapeutics (Wiley Series on Pharmaceutical Science and Biotechnology: Practices, Applications and Methods) 🔍
Xiaohui (Sophia) Xu, Weifeng Xu, Mike S. Lee Wiley & Sons, Limited, John, Hoboken, NJ, 2022
英语 [en] · PDF · 8.4MB · 2022 · 📘 非小说类图书 · 🚀/lgli/zlib · Save
描述
Bioanalytical Aspects in Biological Therapeutics Deepen your understanding of how critical data are generated from bioanalysisIn Bioanalytical Aspects in Biological Therapeutics , a team of renowned chemists, immunologists, and biologists delivers a timely and practical exploration of the diverse scientific and technical literature on the bioanalytical investigation of current biotherapeutics under development. The book discusses the challenges and considerations for bioanalytical support, covering a wide range of central topics in the field, including overview and basic immunology for testing of biological therapeutics, pharmacokinetic aspects, clinical immunogenicity prediction and testing, biomarker testing, biotransformation assessment for biologics, statistical aspects of bioanalytical testing, regulatory expectations, and more.Drug development and analysis professionals will learn how critical data are generated from bioanalysis and how proven tools and methods are applied to the development of biologics. Alongside coverage of topics like PK, immunogenicity, neutralizing antibody assays, and the importance of quality control for reagents, readers will benefit from:A thorough overview of the development of biotherapeutics and the role played by bioanalytical tests, as well as basic immunology for bioanalytical testing of biological therapeuticsComprehensive explorations of platform and instrument considerations in bioanalytical testing, pharmacokinetics assays, and biomarker analysis using LC-MS, LBA, and other technologiesPractical discussions of immunogenicity prediction, preclinical and clinical anti-drug antibody assays, and bioanalytical schemes for anti-drug neutralizing antibody assaysIn-depth examinations of critical reagents in bioanalysisRegulatory expectations for bioanalytical method development, validation, and sample testing
备用文件名
zlib/Medicine/Clinical Medicine/Xiaohui (Sophia) Xu, Weifeng Xu/Bioanalytical Aspects in Biological Therapeutics_21944010.pdf
备用出版商
John Wiley & Sons, Incorporated
备用出版商
American Geophysical Union
备用出版商
Wiley-Blackwell
备用版本
United States, United States of America
备用版本
1, 2022
备用版本
2021
开源日期
2022-07-14
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