{"product_id":"bioanalytical-aspects-in-biological-therapeutics-isbn-9781119523215","title":"Bioanalytical Aspects in Biological Therapeutics","description":"\u003cb\u003eBioanalytical Aspects in Biological Therapeutics\u003c\/b\u003e \u003cp\u003e\u003cb\u003eDeepen your understanding of how critical data are generated from bioanalysis\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003eIn \u003ci\u003eBioanalytical Aspects in Biological Therapeutics\u003c\/i\u003e, 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. \u003c\/p\u003e\u003cp\u003eDrug 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: \u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eA thorough overview of the development of biotherapeutics and the role played by bioanalytical tests, as well as basic immunology for bioanalytical testing of biological therapeutics\u003c\/li\u003e \u003cli\u003eComprehensive explorations of platform and instrument considerations in bioanalytical testing, pharmacokinetics assays, and biomarker analysis using LC-MS, LBA, and other technologies\u003c\/li\u003e \u003cli\u003ePractical discussions of immunogenicity prediction, preclinical and clinical anti-drug antibody assays, and bioanalytical schemes for anti-drug neutralizing antibody assays\u003c\/li\u003e \u003cli\u003eIn-depth examinations of critical reagents in bioanalysis\u003c\/li\u003e \u003cli\u003eRegulatory expectations for bioanalytical method development, validation, and sample testing\u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003ePerfect for pharmaceutical scientists in industry, \u003ci\u003eBioanalytical Aspects in Biological Therapeutics \u003c\/i\u003ewill also earn a place in the libraries of pharmaceutical regulators and other professionals working in pharmaceutical companies, as well as graduate students studying bioanalytical assays for biological therapeutics. \u003c\/p\u003e\u003cp\u003ePreface vii\u003cbr\u003e\u003ci\u003eXiaohui Xu and Weifeng Xu\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eForeword ix\u003cbr\u003e\u003ci\u003eBinodh DeSilva\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eAcknowledgments xiii\u003c\/p\u003e \u003cp\u003eAbout the Editors xv\u003c\/p\u003e \u003cp\u003eList of Contributors xvii\u003c\/p\u003e \u003cp\u003e1 Overview of the Development of Biotherapeutics and the Role of Bioanalytical Sciences 1\u003cbr\u003e\u003ci\u003eRobert Dodge\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2 Basic Immunology for Bioanalytical Testing of Biotherapeutics 23\u003cbr\u003e\u003ci\u003eKang Chen and Weifeng Xu\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3 Platform and Instrument Considerations in Bioanalytical Testing 51\u003cbr\u003e\u003ci\u003eDominic Warrino and Franklin Spriggs\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4 Pharmacokinetic Assays 67\u003cbr\u003e\u003ci\u003eTong-Yuan Yang and Eric Wakshull\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5 Recent Progress in Biomarker Bioanalysis and Target Engagement Assessment 87\u003cbr\u003e\u003ci\u003eYan G. Ni, Lindsay E. King and Carmen Fernández-Metzler\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6 Immunogenicity Risk Assessment for Biotherapeutics 141\u003cbr\u003e\u003ci\u003eJochem Gokemeijer\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7 Bioanalytical Strategy to Support Clinical Immunogenicity Assessment: Anti-drug Antibodies 159\u003cbr\u003e\u003ci\u003eYing Wang and Michael Luong\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8 Bioanalytical Scheme for Antidrug Neutralizing Antibody Assays 185\u003cbr\u003e\u003ci\u003eWeifeng Xu, Bonnie Wu and Jim McNally\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9 Critical Reagents in Bioanalysis 209\u003cbr\u003e\u003ci\u003eYang Xu, Agostinho Gomes Rocha, Shannon Chilewski, Krisna C. Duong-Ly, Kun Yang and Jonathan Haulenbeek\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10 Statistical Aspects of Bioanalytical Testing 239\u003cbr\u003e\u003ci\u003eArkady M. Gershteyn and Mark Ma\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11 Bioanalytical Aspects in Biological Therapeutics: Biotransformation 277\u003cbr\u003e\u003ci\u003eWenying Jian, Cong Wei and Jinping Gan\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12 New Modalities: Multidomain Therapeutics and Gene Therapy Programs 309\u003cbr\u003e\u003ci\u003eKelly Colletti and Mark Ma\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13 Regulatory Aspects for Assay Development, Validation, and Sample Analysis 327\u003cbr\u003e\u003ci\u003eAmy Lavelle and Megan Wiberg\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIndex 355\u003c\/p\u003e \u003cp\u003e\u003cb\u003eXiaohui Xu, PhD, \u003c\/b\u003eis Director at Daiichi-Sankyo Inc. She is actively serving in the American Association of Pharmaceutical Scientists (AAPS) PK Assay Group and IQ Consortium Metabolite Working Group. She has extensive experiences in regulated bioanalytical field including global submissions, covering small molecules, biologics and new modalities. She has extensive publications and 2 book chapters.\u003cb\u003e \u003c\/b\u003eShe received her Doctorate in Pharmaceutical Analysis from College of Pharmacy, the University of Georgia.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eWeifeng Xu, PhD, \u003c\/b\u003eis Director at Merck \u0026amp; Co., Inc. He is an active member and leader in the AAPS and the European Bioanalysis Forum’s (EBF) immunogenicity community and has published multiple papers on immunogenicity assay development and validation.\u003cb\u003e \u003c\/b\u003eHe is also co-leading the IQ Consortium Bioanalytical Considerations and Challenges for Cell Therapies subgroup. More recently Weifeng also became Bioanalytic lead to multiple vaccine projects within Merck including COVID-19 and pneumococcal to oversee all clinical immunogenicity assays.   \u003c\/p\u003e\u003cp\u003e\u003cb\u003eDeepen your understanding of how critical data are generated from bioanalysis\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eIn \u003ci\u003eBioanalytical Aspects in Biological Therapeutics\u003c\/i\u003e, 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. \u003c\/p\u003e\u003cp\u003eDrug 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: \u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eA thorough overview of the development of biotherapeutics and the role played by bioanalytical tests, as well as basic immunology for bioanalytical testing of biological therapeutics\u003c\/li\u003e \u003cli\u003eComprehensive explorations of platform and instrument considerations in bioanalytical testing, pharmacokinetics assays, and biomarker analysis using LC-MS, LBA, and other technologies\u003c\/li\u003e \u003cli\u003ePractical discussions of immunogenicity prediction, preclinical and clinical anti-drug antibody assays, and bioanalytical schemes for anti-drug neutralizing antibody assays\u003c\/li\u003e \u003cli\u003eIn-depth examinations of critical reagents in bioanalysis\u003c\/li\u003e \u003cli\u003eRegulatory expectations for bioanalytical method development, validation, and sample testing\u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003ePerfect for pharmaceutical scientists in industry, \u003ci\u003eBioanalytical Aspects in Biological Therapeutics \u003c\/i\u003ewill also earn a place in the libraries of pharmaceutical regulators and other professionals working in pharmaceutical companies, as well as graduate students studying bioanalytical assays for biological therapeutics.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47988812906725,"sku":"NP9781119523215","price":195.0,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781119523215.jpg?v=1761781690","url":"https:\/\/k12savings.com\/es\/products\/bioanalytical-aspects-in-biological-therapeutics-isbn-9781119523215","provider":"K12savings","version":"1.0","type":"link"}