Home > Books > Validation of Cell-Based Assays in the GLP Setting: A Practical Guide
Validation of Cell-Based Assays in the GLP Setting: A Practical Guide
View PDF

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

Publication Year: 2008
Edition: 1st
Authors/Editor: Prabhakar, Uma; Kelley, Marian
Publisher: Wiley
ISBN: 978-0-470-02876-6
  • Description
  • Details

Validation of Cell-based Assays in the GLP Setting provides the professional with an invaluable reference source, featuring key 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.

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

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.

  • Platform:
  • Publisher: Wiley
  • Product Type: Book
  • Author/Editor: Prabhakar, Uma; Kelley, Marian
  • ISBN: 978-0-470-02876-6
  • Specialty:
  • Language: English
  • Edition: 1st
  • Pages: 312
  • Illustrations: 0
  • Year: 2008

Free Instant Access
This Month

Evidence-Based Medicine Reviews (EBMR) A definitive resource for electronic information in the evidence based medicine movement that combines the most trusted resources into a single, fully-searchable database.
Global Health The only specialist bibliographic abstracting and indexing database dedicated to public health and capturing key literature that is not covered by other databases.
Clinical Orthopaedics and Related Research® Original articles highlighting the latest in clinically relevant basic science of musculoskeletal diseases and their treatments.
Annals of Internal Medicine Published by the American College of Physicians, contains original articles, case reports, topical reviews, editorials, book reviews and medical notices for internal medicine.


Doody's Featured Books
Osborn's Brain: Imaging, Pathology, and Anatomy
Covers the must-know aspects of brain imaging together with spectacular pathology examples, relevant anatomy, and up-to-date techniques in neuroradiology.

Neurology Evidence: The Practice-Changing Studies
Synthesizes the vast body of literature available in neurology into one accessible, clinically relevant volume-features papers that have had the most impact on changing clinical practice.