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Product 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.
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 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.
This book:
- Describes the development, optimization and validation of cell-based assays, including procedural documentation required for Good Laboratory Practice
- Presents validations of cell-based assays for select targets, with step-by-step instructions, allowing the reader to reproduce the assay conditions and results
- Provides details of techniques used in the evaluation of immunodeficiency, autoimmune and oncological disorders, including assessment of cancer vaccines
- Offers a compendium of validation parameters that need to be considered when using these methods to develop a new drug
- Includes detailed protocols for the evaluation of cytokines and of neutralizing antibodies directed against protein therapeutics
Validation of Cell-based Assays in the GLP Setting 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.
From the Back Cover
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 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.
This book:
- Describes the development, optimization and validation of cell-based assays, including procedural documentation required for Good Laboratory Practice
- Presents validations of cell-based assays for select targets, with step-by-step instructions, allowing the reader to reproduce the assay conditions and results
- Provides details of techniques used in the evaluation of immunodeficiency, autoimmune and oncological disorders, including assessment of cancer vaccines
- Offers a compendium of validation parameters that need to be considered when using these methods to develop a new drug
- Includes detailed protocols for the evaluation of cytokines and of neutralizing antibodies directed against protein therapeutics
Validation of Cell-based Assays in the GLP Setting 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.
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Inside This Book
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Key Phrases - Statistically Improbable Phrases (SIPs):
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master bank, normal donor samples, good laboratory practice studies, clinical sample testing, mean spot number, peripheral whole blood samples, interplate variability, spot forming cells, clinical study samples, cell surface marker expression, using whole blood samples, shipped samples, neutralization bioassays, data acceptance criteria, optimal cell density, qualification experiments, cell immunogenicity, maintain full functionality, assay robustness, assay outcome, critical reagents, mock samples, cryopreserved samples, assay validation, stimulated samples Key Phrases - Capitalized Phrases (CAPs): (learn more)
Mean Donor, Immunol Methods, Validation of Cell-Based Assays, Practical Guide Editors, John Wiley, King of Prussia Road, Proc Natl Acad Sci, San Diego, Nat Med, Clin Diagn Lab Immunol, Res Hum Retroviruses, Study Plan, Clin Immunol, Pharm Res, Code of Federal Regulations, Manjula Reddy, New York, Study Director, Infect Dis, Exp Med, Validated Method, Clin Transplant, Neurol Sci, Biological Specialty Corporation, San Jose Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Surprise Me!
master bank, normal donor samples, good laboratory practice studies, clinical sample testing, mean spot number, peripheral whole blood samples, interplate variability, spot forming cells, clinical study samples, cell surface marker expression, using whole blood samples, shipped samples, neutralization bioassays, data acceptance criteria, optimal cell density, qualification experiments, cell immunogenicity, maintain full functionality, assay robustness, assay outcome, critical reagents, mock samples, cryopreserved samples, assay validation, stimulated samples Key Phrases - Capitalized Phrases (CAPs): (learn more)
Mean Donor, Immunol Methods, Validation of Cell-Based Assays, Practical Guide Editors, John Wiley, King of Prussia Road, Proc Natl Acad Sci, San Diego, Nat Med, Clin Diagn Lab Immunol, Res Hum Retroviruses, Study Plan, Clin Immunol, Pharm Res, Code of Federal Regulations, Manjula Reddy, New York, Study Director, Infect Dis, Exp Med, Validated Method, Clin Transplant, Neurol Sci, Biological Specialty Corporation, San Jose Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Surprise Me!
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