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OverviewThis volume provides practical information for the development of successful commercial immunodiagnostic product based on enzyme immunoassay technology. The reader is taken through all stages of this process from conceptualization, product design and manufacture to introduction of the product to the market. The information is presented in three different parts. Part I covers the basic considerations, such as classification, structure and function of antibodies, Part II covers the actual prodcut development process and Part III describes the regulatory requirements, the importance of laboratory, clinical and manufacturing practices, and certain international marketing requirements. Full Product DetailsAuthor: S.S. DeshpandePublisher: Chapman and Hall Imprint: Chapman and Hall Edition: 1996 ed. Dimensions: Width: 15.60cm , Height: 2.60cm , Length: 23.40cm Weight: 1.870kg ISBN: 9780412056017ISBN 10: 0412056011 Pages: 464 Publication Date: 30 June 1996 Audience: College/higher education , Professional and scholarly , Undergraduate , Postgraduate, Research & Scholarly Format: Hardback Publisher's Status: Active Availability: In Print This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us. Table of ContentsI: Basic Considerations (Concepts).- 1 Introduction.- 2 Antibodies: Biochemistry, Structure, and Function.- 3 Antigen-Antibody Reactions.- 4 Conjugation Techniques.- 5 Antibody Production.- 6 Enzymes and Signal Amplification Systems.- 7 Separation and Solid-Phase Systems.- II: Product Development.- 8 Immunoassay Classification and Commercial Technologies.- 9 Assay Development, Evaluation, and Validation.- 10 Reagent Formulations and Shelf Life Evaluation.- 11 Data Analysis.- 12 Documentation, Registration, and Diagnostics Start-Ups.Reviews`... all those who read this book will be far richer in their knowledge of enzyme immunoassays and their application.' Chemistry and Industry `...if you're looking for a book that describes immunoassay methods in general then this one has something to recommend it...if you are looking to go beyond the laboratory and develop commercial assays then this book is worth buying for its second half alone.' Analyst ... all those who read this book will be far richer in their knowledge of enzyme immunoassays and their application.' Chemistry and Industry ...if you're looking for a book that describes immunoassay methods in general then this one has something to recommend it...if you are looking to go beyond the laboratory and develop commercial assays then this book is worth buying for its second half alone.' Analyst Author InformationTab Content 6Author Website:Countries AvailableAll regions |
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