{"product_id":"validation-of-cell-based-assays-in-the-glp-setting-isbn-9780470028766","title":"Validation of Cell-Based Assays in the GLP Setting","description":"The use of cell-based assays within pharmaceutical and biotechnology companies is driven in large part by the need to evaluate the plethora of drug targets derived from genomics and proteomics. In addition, the potential of biomarkers to facilitate the development of effective and safe drugs is being recognized as an integral part of all phases of drug development, and cell-based technologies are a critical part of biomarker discovery and development. Despite this critical role, cell-based assays have not been standardized and made compliant with Good Laboratory Practice guidelines.    \u003cp\u003eIn this book, the editors have collected assays for which validation procedures have been developed, making this a vital purchase for anyone using such assays in drug development.\u003c\/p\u003e \u003cp\u003eThis book: \u003c\/p\u003e \u003cul\u003e \u003cli\u003eDescribes the development, optimization and validation of cell-based assays, including procedural documentation required for Good Laboratory Practice\u003c\/li\u003e \u003cli\u003ePresents validations of cell-based assays for select targets, with step-by-step instructions, allowing the reader to reproduce the assay conditions and results\u003c\/li\u003e \u003cli\u003eProvides details of techniques used in the evaluation of immunodeficiency, autoimmune and oncological disorders, including assessment of cancer vaccines\u003c\/li\u003e \u003cli\u003eOffers a compendium of validation parameters that need to be considered when using these methods to develop a new drug\u003c\/li\u003e \u003cli\u003eIncludes detailed protocols for the evaluation of cytokines and of neutralizing antibodies directed against protein therapeutics\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003e\u003ci\u003eValidation of Cell-based Assays in the GLP Setting\u003c\/i\u003e provides the professional with an invaluable reference source, featuring key guidelines. The book will prove extremely useful to all scientists working in the areas of drug development. \u003c\/p\u003e \u003cp\u003eList of contributors ix\u003c\/p\u003e \u003cp\u003ePreface xiii\u003c\/p\u003e \u003cp\u003eIntroduction xvii\u003cbr\u003e \u003ci\u003eUma Prabhakar\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e1 Considerations while setting up cell-based assays 1\u003cbr\u003e \u003ci\u003eMarian Kelley\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2 Development, optimization and validation of cell-based assays – 1 11\u003cbr\u003e \u003ci\u003eMarielena Mata and Thomas Lohr\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3 Development, optimization and validation of cell-based assays – 2 25\u003cbr\u003e \u003ci\u003eManjula Reddy and Uma Prabhakar\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4 Whole blood ex vivo stimulation assay development, optimization and validation 37\u003cbr\u003e \u003ci\u003eManjula Reddy and Uma Prabhakar\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5 Immunohistochemistry assays in Good Laboratory Practice studies 49\u003cbr\u003e \u003ci\u003eFrank Lynch, Steve Bernstein and Hector Battifora\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6 Flow cytometric cell-based assays: an overview of general applications 73\u003cbr\u003e \u003ci\u003eCuc Davis, Manjula Reddy, Thomas Williams and Uma Prabhakar\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7 T-cell surface markers in human peripheral whole blood using flow cytometry 85\u003cbr\u003e \u003ci\u003eManjula Reddy, Cuc Davis, Hugh Davis, Charles Pendley and Uma Prabhakar\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8 Intracellular cytokine detection by flow cytometry 107\u003cbr\u003e \u003ci\u003eJulie G. Wilkinson, Carlos A. Aparicio and Wade E. Bolton\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9 Validating reference samples for comparison in a regulated ELISPOT assay 127\u003cbr\u003e \u003ci\u003eMagdalena Tary-Lehmann, Christina D. Hamm and Paul V. Lehmann\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10 IFN-γ ELISPOT assay validation 147\u003cbr\u003e \u003ci\u003eManjula Reddy, Jackson Wong, Charles Pendley and Uma Prabhakar\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11 IL-5 ELISPOT assay validation 173\u003cbr\u003e \u003ci\u003eManjula Reddy, Jackson Wong, Hugh Davis, Charles Pendley and Uma Prabhakar\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12 Validation of the Cylex technology to measure T and B cell activation capacity in clinical trials 193\u003cbr\u003e \u003ci\u003eMarielena Mata, Thomas Lohr and Jaymala Patel\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13 Development of validated neutralization bioassays 209\u003cbr\u003e \u003ci\u003eManoj Rajadhyaksha, Manjula Reddy, Jaime Bald, Amy Fraunfelter, Persymphonie Miller, Marian Kelley and Uma Prabhakar\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e14 Endpoint assays in HIV-1 vaccine trials: functioning in a Good Laboratory Practices environment 239\u003cbr\u003e \u003ci\u003ePatricia D’Souza, Josephine H. Cox, Guido Ferrari, Nina Thapa Kunwar, Victoria Polonis and Marcella Sarzotti-Kelsoe\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15 The future direction of cell-based assays 277\u003cbr\u003e \u003ci\u003eUma Prabhakar and Marian Kelley\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIndex 283\u003c\/p\u003e  \u003cb\u003eUma Prabhakar\u003c\/b\u003e, Ph. D. Director, Department of Clinical Pharmacology \u0026amp; Experimental Medicine, Centocor Inc, PA, USA  \u003cp\u003e\u003cb\u003eMarian Kelley,\u003c\/b\u003e M.A., Director of Compliance, Department of Clinical Pharmacology \u0026amp; Experimental Medicine, Centocor Inc, PA, USA\u003c\/p\u003e  The use of cell-based assays within pharmaceutical and biotechnology companies is driven in large part by the need to evaluate the plethora of drug targets derived from genomics and proteomics. In addition, the potential of biomarkers to facilitate the development of effective and safe drugs is being recognized as an integral part of all phases of drug development, and cell-based technologies are a critical part of biomarker discovery and development. Despite this critical role, cell-based assays have not been standardized and made compliant with Good Laboratory Practice guidelines.  \u003cp\u003eIn this book, the editors have collected assays for which validation procedures have been developed, making this a vital purchase for anyone using such assays in drug development.\u003c\/p\u003e \u003cp\u003eThis book:\u003c\/p\u003e \u003cul\u003e \u003cli\u003eDescribes the development, optimization and validation of cell-based assays, including procedural documentation required for Good Laboratory Practice\u003c\/li\u003e \u003c\/ul\u003e \u003cul\u003e \u003cli\u003ePresents validations of cell-based assays for select targets, with step-by-step instructions, allowing the reader to reproduce the assay conditions and results\u003c\/li\u003e \u003c\/ul\u003e \u003cul\u003e \u003cli\u003eProvides details of techniques used in the evaluation of immunodeficiency, autoimmune and oncological disorders, including assessment of cancer vaccines\u003c\/li\u003e \u003c\/ul\u003e \u003cul\u003e \u003cli\u003eOffers a compendium of validation parameters that need to be considered when using these methods to develop a new drug\u003c\/li\u003e \u003c\/ul\u003e \u003cul\u003e \u003cli\u003eIncludes detailed protocols for the evaluation of cytokines and of neutralizing antibodies directed against protein therapeutics\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003e\u003cb\u003eValidation of Cell-based Assays in the GLP Setting\u003c\/b\u003e will provide the professional with an invaluable reference source, featuring key guidelines, and will prove extremely useful to all scientists working in the areas of drug development.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47990443802853,"sku":"NP9780470028766","price":216.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9780470028766.jpg?v=1761787852","url":"https:\/\/k12savings.com\/es\/products\/validation-of-cell-based-assays-in-the-glp-setting-isbn-9780470028766","provider":"K12savings","version":"1.0","type":"link"}