Validation of cell-based assays in the GLP setting : a practical guide / edited by Uma Prabhakar and Marian Kelley.

Includes bibliographical references and index.

Considerations while setting up cell-based assays / Marian Kelley -- Development, optimization and validation of cell based assays 1 / Marielena Mata and Thomas Lohr -- Development, optimization and validation of cell based assays 2 / Manjula Reddy and Uma Prabhakar -- Whole blood ex vivo stimulation assay development, optimization and validation / Manjula Reddy and Uma Prabhakar -- Immunohistochemistry assays in GLP studies / Frank Lynch [and others] -- Flow cytometric cell based assays : an overview of general applications / Cuc Davis [and others] -- T-cell surface markers in human peripheral whole blood using flow cytometry / Manjula Reddy [and others] -- Intracellular cytokine detection by flow cytometry / Julie G. Wilkinson, Carlos A. Aparicio and Wade E. Bolton -- Validating reference samples for comparison in regulated ELISPOT assay / Magdalena Tary-Lehmann, Christina D. Hamm and Paul V. Lehmann -- IFN-[gamma] ELISPOT assay validation / Manjula Reddy [and others] -- IL-5 ELISPOT assay validation / Manjula Reddy [and others] -- Validation of the cylex technology to measure T and B cell activation capacity in clinical trials / Marielena Mata, Thomas Lohr and Jaymala Patel -- Development of validated neutralization bioassays / Manoj Rajadhyaksha [and others] -- Endpoint assays in HIV-1 vaccine trials : functioning in a GLP environment / Patricia D'Souza [and others] -- The future direction of cell-based assays / Uma Prabhakar and Marian Kelley.

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. In this.

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