{"product_id":"ligand-binding-assays-development-validation-and-implementation-in-the-drug-development-arena-hardback-9780470041383","title":"Ligand-Binding Assays; Development, Validation, and Implementation in the Drug Development Arena (Hardback) 9780470041383","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eLigand-Binding Assays\u003c\/font\u003e\u003cbr\u003e\r\n\u003cfont size=\"5\"\u003eDevelopment, Validation, and Implementation in the Drug Development Arena\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\u003cp\u003e\u003cfont size=\"4\"\u003eMasood N. Khan (Edited by), MN Khan (Author), John W. A. Findlay (Edited by)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9780470041383, Wiley\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eHardback, published 24 November 2009\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e432 pages\u003cbr\u003e24.3 x 16.1 x 2.4 cm, 0.703 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cem\u003e\u003cfont size=\"3\"\u003e\"Ligand-Binding Assays, written by recognized and respected industry experts, covers a wide range of topics that provide valuable information to someone who is new to the field.\" (\u003ci\u003eNews \u0026amp; Analysis\u003c\/i\u003e, 2011)  \u003cp\u003e\"\u003ci\u003eLigand-Binding Assays\u003c\/i\u003e, edited by Masood Kahn and John Findlay offers a comprehensive, in depth description of all aspects of the subject. The editors are directly involved in the ligand-binding assay field and individual chapters are written by experts with a thorough understanding of the specific topics. The book is easy to read, clear and well illustrated. The emphasis is on biologicals rather than small molecules and this reflects the current application of many of the procedures covered. There is a good overview of assay validation, and this book is highly recommended for those with an interest in the topic.\"\u003cbr\u003e —\u003cb\u003eRobin Thorpe\u003c\/b\u003e, PhD FRCPath, National Institute for Biological Standards and Control\u003c\/p\u003e \u003cp\u003e\"This book is a collection of valuable articles describing these assays in some detail, both from a historical perspective ..., but also regarding the new developments in the field, such as new technologies to support drug development ... and pharmacokinetic research.\" (ChemMedChem, July 2010)\u003c\/p\u003e\u003c\/font\u003e\u003c\/em\u003e\u003c\/p\u003e\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003e\u003cb\u003eA consolidated and comprehensive reference on ligand-binding assays\u003c\/b\u003e  \u003cp\u003eLigand-binding assays (LBAs) stand as the cornerstone of support for definition of the pharmaco-kinetics and toxicokinetics of macromolecules, an area of burgeoning interest in the pharmaceutical industry. Yet, outside of the Crystal City Conference proceedings, little guidance has been available for LBA validation, particularly for assays used to support macromolecule drug development. \u003ci\u003eLigand-Binding Assays: Development, Validation, and Implementation in the Drug Development Arena\u003c\/i\u003e answers that growing need, serving as a reference text discussing critical aspects of the development, validation, and implementation of ligand-binding assays in the drug development field.\u003c\/p\u003e \u003cp\u003e\u003ci\u003eLigand-Binding Assays\u003c\/i\u003e covers essential topics related to ligand-binding assays, from pharmacokinetic studies, the development of LBAs, assay validation, statistical LBA aspects, and regulatory aspects, to software for LBAs and robotics and other emerging methodologies for LBAs. Highlights include:\u003c\/p\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eA general discussion of challenges and proven approaches in the development of ligand-binding assays\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eMore detailed examination of characteristics of these assays when applied to support of pharmacokinetic and toxicokinetic studies of compounds at different stages in the discovery or development timeline\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eA concise, but detailed, discussion of validation of ligand-binding assays for macromolecules\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eA practical approach to \"fit-for-purpose\" validation of assays for biomarkers, those molecules receiving increased attention as potentially demonstrating that the target chosen in discovery is being modulated by the candidate therapeutic, both in nonclinical and clinical studies\u003c\/p\u003e \u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eWritten by a team of world-recognized authorities in the field, \u003ci\u003eLigand-Binding Assays\u003c\/i\u003e provides key information to a broad range of practitioners, both in the pharmaceutical and allied industries and in related contract research organizations and academic laboratories and, perhaps, even in the field of diagnostics and clinical chemistry.\u003c\/p\u003e\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003ePreface.  \u003cp\u003eContributors.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Ligand-Binding Assays in Drug Development: Introduction and Historical Perspective\u003c\/b\u003e (\u003ci\u003eJohn W.A. Findlay and Masood N. Khan\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e1.1 General.\u003c\/p\u003e \u003cp\u003e1.2 Historical Review.\u003c\/p\u003e \u003cp\u003e1.3 LBAs for Macromolecules.\u003c\/p\u003e \u003cp\u003e1.4 Advantages and Limitations of LBAs.\u003c\/p\u003e \u003cp\u003e1.5 Ligand-Binding Assay Bioanalytical Focus Group of AAPS.\u003c\/p\u003e \u003cp\u003e1.6 Scope of the Present Volume.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Ligand-Binding Assays to Support Disposition Studies of Macromolecular Therapeutics\u003c\/b\u003e (\u003ci\u003eMarian M. Kelley, Marjorie A. Mohler, and John W.A. Findlay\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e2.1 Introduction.\u003c\/p\u003e \u003cp\u003e2.2 Differences Between Low Molecular Weight Molecules and Macromolecules.\u003c\/p\u003e \u003cp\u003e2.3 LBA Assay Considerations Relative to Research and Development Stage.\u003c\/p\u003e \u003cp\u003e2.4 Critical Future Challenges for Ligand-Binding Assays.\u003c\/p\u003e \u003cp\u003e2.5 Conclusions.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Development of Ligand-Binding Assays for Drug Development Support\u003c\/b\u003e (\u003ci\u003eMasood N. Khan, Proveen D. Dass, John H. Leete, Richard F. Schuman, Michele Gunsior, and Chanchal Sadhu\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e3.1 Introduction.\u003c\/p\u003e \u003cp\u003e3.2 Inherent Complexities of Immunoassay Development.\u003c\/p\u003e \u003cp\u003e3.3 Steps in the Development of a Validatable Immunoassay.\u003c\/p\u003e \u003cp\u003e3.4 Development and Optimization of an Immunoassay.\u003c\/p\u003e \u003cp\u003e3.5 Optimization of Commercial Kit-Based Assays.\u003c\/p\u003e \u003cp\u003e3.6 Troubleshooting Immunoassays.\u003c\/p\u003e \u003cp\u003e3.7. Conclusions.\u003c\/p\u003e \u003cp\u003eAcknowledgments.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Biotherapeutics\u003c\/b\u003e (\u003ci\u003eBinodh S. DeSilva and Ronald R. Bowsher\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e4.1 Introduction.\u003c\/p\u003e \u003cp\u003e4.2 Assay Development and Validation Paradigm.\u003c\/p\u003e \u003cp\u003e4.3 Prestudy Validation Phase.\u003c\/p\u003e \u003cp\u003e4.4 Analytical Performance Characteristics.\u003c\/p\u003e \u003cp\u003e4.5 In-Study Validation Phase.\u003c\/p\u003e \u003cp\u003e4.6 Partial Validations\/Method Transfer\/Cross-Validation.\u003c\/p\u003e \u003cp\u003e4.7 Documentation.\u003c\/p\u003e \u003cp\u003e4.8 Conclusions.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Statistical Considerations in the Validation of Ligand-Binding Assays\u003c\/b\u003e (\u003ci\u003eBruno Boulanger, Viswanath Devanarayan, and Walthère Dewé\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e5.1 Introduction.\u003c\/p\u003e \u003cp\u003e5.2 Objectives of Assay Validation.\u003c\/p\u003e \u003cp\u003e5.3 Validation Criteria.\u003c\/p\u003e \u003cp\u003e5.4 Estimating Assay Performance Characteristics.\u003c\/p\u003e \u003cp\u003e5.5 Decision Rules and Risk Assessment in Prestudy Validation.\u003c\/p\u003e \u003cp\u003e5.6 Decision Rules During In-Study Phase and Associated Risks.\u003c\/p\u003e \u003cp\u003e5.7 Reconciling Validation and Routine Decision Rules.\u003c\/p\u003e \u003cp\u003e5.8 Conclusions.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Development and Validation of Ligand-Binding Assays for Biomarkers\u003c\/b\u003e (\u003ci\u003eJean W. Lee, Yang Pan, Peter J. O’Brien, and Ren Xu\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e6.1 Introduction.\u003c\/p\u003e \u003cp\u003e6.2 Preanalytical Considerations and Method Feasibility.\u003c\/p\u003e \u003cp\u003e6.3 Method Development and Method Qualification for Exploratory Applications.\u003c\/p\u003e \u003cp\u003e6.4 Method Development and Method Validation for Advanced Applications.\u003c\/p\u003e \u003cp\u003e6.5 Partial Validation for Change Control.\u003c\/p\u003e \u003cp\u003e6.6 Documentation, Record Keeping, and Reporting.\u003c\/p\u003e \u003cp\u003e6.7 Regulatory Issues.\u003c\/p\u003e \u003cp\u003e6.8 In-study Validation.\u003c\/p\u003e \u003cp\u003e6.9 Conclusions.\u003c\/p\u003e \u003cp\u003eAcknowledgments.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 The Use of Commercial Assay Kits for PK\/PD Analysis in Drug Development\u003c\/b\u003e (\u003ci\u003eJohn L. Allinson and John D. Chappell\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e7.1 Introduction.\u003c\/p\u003e \u003cp\u003e7.2 Validation Definitions That May be Interpreted Inconsistently.\u003c\/p\u003e \u003cp\u003e7.3 Validation Experiments.\u003c\/p\u003e \u003cp\u003e7.4 Stability.\u003c\/p\u003e \u003cp\u003e7.5 Reoptimizing Reagent Concentrations.\u003c\/p\u003e \u003cp\u003e7.6 The Use of Commercial Kits for PK and TK Assays.\u003c\/p\u003e \u003cp\u003e7.7 Matrix Problems.\u003c\/p\u003e \u003cp\u003e7.8 Changing Method Protocol.\u003c\/p\u003e \u003cp\u003e7.9 Conclusions.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Development and Validation of Immunogenicity Assays for Preclinical and Clinical Studies\u003c\/b\u003e (\u003ci\u003eThomas H. Parish, Deborah Finco, and Viswanath Devanarayan\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e8.1 Introduction.\u003c\/p\u003e \u003cp\u003e8.2 Immunogenicity Risk-Based Strategy.\u003c\/p\u003e \u003cp\u003e8.3 Regulatory Guidance.\u003c\/p\u003e \u003cp\u003e8.4 Assay Design.\u003c\/p\u003e \u003cp\u003e8.5 Optimization and Validation: Total Binding Antibody Assays.\u003c\/p\u003e \u003cp\u003e8.6 Optimization and Validation: Neutralizing Antibody Assays.\u003c\/p\u003e \u003cp\u003e8.7 Assays and Risk Assessment.\u003c\/p\u003e \u003cp\u003e8.8 Application and Interpretation of Data.\u003c\/p\u003e \u003cp\u003e8.9 Conclusions.\u003c\/p\u003e \u003cp\u003e8.10 Appendix 8.A Illustration of Screening Cut Point Evaluation.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Macromolecular Reference Standards for Biotherapeutic Pharmacokinetic Analysis\u003c\/b\u003e (\u003ci\u003eMarie T. Rock and Stephen Keller\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e9.1 Introduction.\u003c\/p\u003e \u003cp\u003e9.2 United States Pharmacopeia.\u003c\/p\u003e \u003cp\u003e9.3 Characterization of Non-USP Reference Standards.\u003c\/p\u003e \u003cp\u003e9.4 The PK Assay.\u003c\/p\u003e \u003cp\u003e9.5 Conclusions.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Strategies for Successful Transfer of Ligand-Binding Assays for Successful Validation and Implementation in GXP Environment\u003c\/b\u003e (\u003ci\u003eWolfgang Klump and Howard Hill\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e10.1 Introduction.\u003c\/p\u003e \u003cp\u003e10.2 Establishing Successful Working Relationships Between Laboratories.\u003c\/p\u003e \u003cp\u003e10.3 Method Transfer.\u003c\/p\u003e \u003cp\u003e10.4 Monitoring the Method Transfer Process.\u003c\/p\u003e \u003cp\u003e10.5 Auditing CROs.\u003c\/p\u003e \u003cp\u003e10.6 Method Troubleshooting.\u003c\/p\u003e \u003cp\u003e10.7 Secrets of Successful Method Transfer.\u003c\/p\u003e \u003cp\u003eAcknowledgments.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Application of Automation in Ligand-Binding Assays\u003c\/b\u003e (\u003ci\u003eChris Morrow\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e11.1 Introduction.\u003c\/p\u003e \u003cp\u003e11.2 Implementing Automated Systems.\u003c\/p\u003e \u003cp\u003e11.3 Specific Ligand-Binding Assay Automation Systems.\u003c\/p\u003e \u003cp\u003e11.4 Automated Sample Dilutors.\u003c\/p\u003e \u003cp\u003e11.5 Assay Robots.\u003c\/p\u003e \u003cp\u003e11.6 Integration: Tying It All Together.\u003c\/p\u003e \u003cp\u003e11.7 Future Directions in Ligand-Binding Assay Automation.\u003c\/p\u003e \u003cp\u003e11.8 Conclusion.\u003c\/p\u003e \u003cp\u003eAcknowledgments.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Documentation and Regulatory Compliance\u003c\/b\u003e (\u003ci\u003eCT. Viswanathan and Jacqueline A. O’Shaughnessy\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e12.1 Regulatory Perspectives in the Documentation of Bioanalytical Data and Reports.\u003c\/p\u003e \u003cp\u003e12.2 Recommendations for Development, Validation, Implementation, and Reporting Phases.\u003c\/p\u003e \u003cp\u003e12.3 Conclusions.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Alternative and Emerging Methodologies in Ligand-Binding Assays\u003c\/b\u003e (\u003ci\u003eHuifen F. Wang and John W.A. Findlay\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e13.1 Introduction.\u003c\/p\u003e \u003cp\u003e13.2 Dissociation-Enhanced Lanthanide Fluoroimmunoassay.\u003c\/p\u003e \u003cp\u003e13.3 Enzyme-Linked Immunospot Assay.\u003c\/p\u003e \u003cp\u003e13.4 Immuno-Polymerase Chain Reaction.\u003c\/p\u003e \u003cp\u003e13.5 Electrochemiluminescence-Based Ligand-Binding Assays.\u003c\/p\u003e \u003cp\u003e13.6 Hybridization-Based Ligand-Binding Assays.\u003c\/p\u003e \u003cp\u003e13.7 Molecularly Imprinted Polymers (Synthetic Antibodies).\u003c\/p\u003e \u003cp\u003e13.8 Surface Plasmon Resonance Methods.\u003c\/p\u003e \u003cp\u003e13.9 Chromatography–Ligand-Binding Assay Coupled Methods, Immunoaffinity Systems, and Online (Flow-Injection) Ligand-Binding Assay Methods.\u003c\/p\u003e \u003cp\u003e13.10 Future Trends and Directions for LBATechnologies.\u003c\/p\u003e \u003cp\u003e13.11 Conclusions.\u003c\/p\u003e \u003cp\u003eAcknowledgment.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003eIndex.\u003c\/p\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Chemistry [\u003ca title=\"See our other books on Chemistry\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Chemistry%20%5BPN%5D%22\"\u003ePN\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Wiley","offers":[{"title":"Brand New","offer_id":52256536887576,"sku":"9780470041383","price":106.99,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/files\/9780470041383.jpg?v=1781274840","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/ligand-binding-assays-development-validation-and-implementation-in-the-drug-development-arena-hardback-9780470041383","provider":"Freshly Printed Books","version":"1.0","type":"link"}