Chapter 2. Development, Optimization and Validation of Cell-Based Assays – 1

  1. Uma Prabhakar Ph.D. and
  2. Marian Kelley Director of Compliance
  1. Marielena Mata Ph.D. and
  2. Thomas Lohr

Published Online: 8 APR 2008

DOI: 10.1002/9780470987810.ch2

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

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

How to Cite

Mata, M. and Lohr, T. (2008) Development, Optimization and Validation of Cell-Based Assays – 1, in Validation of Cell-Based Assays in the GLP Setting: A Practical Guide (eds U. Prabhakar and M. Kelley), John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/9780470987810.ch2

Editor Information

  1. Department of Clinical Pharmacology & Experimental Medicine, Centocor Research and Development, Inc., 145 King of Prussia Road, Radnor, PA 19087, USA

Author Information

  1. Department of Clinical Pharmacology & Experimental Medicine, Centocor Research and Development, Inc., 145 King of Prussia Road, Radnor, PA 19087, USA

Publication History

  1. Published Online: 8 APR 2008
  2. Published Print: 21 MAR 2008

ISBN Information

Print ISBN: 9780470028766

Online ISBN: 9780470987810

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Keywords:

  • Good laboratory practices;
  • validation;
  • cell-based assay;
  • bioassay;
  • FDA regulations;
  • standard operating procedures

Summary

This chapter contains sections titled:

  • Introduction

  • Definitions

  • Assay development and optimization

  • Assay validation

  • Data analysis storage and handling

  • Acceptance criteria

  • References