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

138,60 €
Disponible
ISBN
0470028769
Edición
1st
Autores
Uma Prabhakar, Marian Kelley
Editorial
Wiley
Fecha Publicacion
1 mar. 2008
Características
N/D
This book describes several complex cell-based assays developed primarily for discovery work that have been adapted to establish validated protocols for the clinical setting under Good Laboratory Practice (GLP) guidelines. This process has been painstaking and time-consuming, particularly because of lack of defined GLP guidelines for establishing such specialized procedures. The resulting validations represent various categories of cell-based assays that will meet GLP standards and will prove extremely useful to all scientists working in these areas.

This practical guide provides the professional with a general, but not trivial, reference source for cell-based bioassay platforms used in the drug development process. It also features a compendium of validation parameters that need to be considered when using these methods to develop a new drug. The book describes actual examples of validations under various categories of cell-based assays. Therapeutic areas addressed include oncology and immunology. 

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