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Validation of Cell-Based Assays in the GLP Setting: A Practical Guide Book

Validation of Cell-Based Assays in the GLP Setting: A Practical Guide
Validation of Cell-Based Assays in the GLP Setting: A Practical Guide, 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 de, Validation of Cell-Based Assays in the GLP Setting: A Practical Guide has a rating of 3 stars
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Validation of Cell-Based Assays in the GLP Setting: A Practical Guide, 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 de, Validation of Cell-Based Assays in the GLP Setting: A Practical Guide
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  • Validation of Cell-Based Assays in the GLP Setting: A Practical Guide
  • Written by author Marian Kelley
  • Published by Wiley, John & Sons, Incorporated, June 2008
  • 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 de
  • 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 de
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Authors

List of contributors     ix
Preface     xiii
Introduction   Uma Prabhakar     xvii
Considerations while setting up cell-based assays   Marian Kelley     1
Development, optimization and validation of cell-based assays - 1   Marielena Mata   Thomas Lohr     11
Development, optimization and validation of cell-based assays - 2   Manjula Reddy   Uma Prabhakar     25
Whole blood ex vivo stimulation assay development, optimization and validation   Manjula Reddy   Uma Prabhakar     37
Immunohistochemistry assays in Good Laboratory Practice studies   Frank Lynch   Steve Bernstein   Hector Battifora     49
Flow cytometric cell-based assays: an overview of general applications   Cuc Davis   Manjula Reddy   Thomas Williams   Uma Prabhakar     73
T-cell surface markers in human peripheral whole blood using flow cytometry   Manjula Reddy   Cuc Davis   Hugh Davis   Charles Pendley   Uma Prabhakar     85
Intracellular cytokine detection by flow cytometry   Julie G. Wilkinson   Carlos A. Aparicio   Wade E. Bolton     107
Validating reference samples for comparisonin a regulated ELISPOT assay   Magdalena Tary-Lehmann   Christina D. Hamm   Paul V. Lehmann     127
IFN-[gamma] ELISPOT assay validation   Manjula Reddy   Jackson Wong   Charles Pendley   Uma Prabhakar     147
IL-5 ELISPOT assay validation   Manjula Reddy   Jackson Wong   Hugh Davis   Charles Pendley   Uma Prabhakar     173
Validation of the Cylex technology to measure T and B cell activation capacity in clinical trials   Marielena Mata   Thomas Lohr   Jaymala Patel     193
Development of validated neutralization bioassays   Manoj Rajadhyaksha   Manjula Reddy   Jaime Bald   Amy Fraunfelter   Persymphonie Miller   Marian Kelley   Uma Prabhakar     209
Endpoint assays in HIV-1 vaccine trials: functioning in a Good Laboratory Practices environment   Patricia D'Souza   Josephine H. Cox   Guido Ferrari   Nina Thapa Kunwar   Victoria Polonis   Marcella Sarzotti-Kelsoe     239
The future direction of cell-based assays   Uma Prabhakar   Marian Kelley     277
Index     283


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Validation of Cell-Based Assays in the GLP Setting: A Practical Guide, 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 de, Validation of Cell-Based Assays in the GLP Setting: A Practical Guide

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Validation of Cell-Based Assays in the GLP Setting: A Practical Guide, 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 de, Validation of Cell-Based Assays in the GLP Setting: A Practical Guide

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Validation of Cell-Based Assays in the GLP Setting: A Practical Guide, 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 de, Validation of Cell-Based Assays in the GLP Setting: A Practical Guide

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