Chapter 8. Preclinical and Clinical Safety Evaluation

  1. John Kelly

Published Online: 13 NOV 2009

DOI: 10.1002/9780470682920.ch8

Principles of CNS Drug Development: From Test Tube to Patient

Principles of CNS Drug Development: From Test Tube to Patient

How to Cite

Kelly, J. (2010) Preclinical and Clinical Safety Evaluation, in Principles of CNS Drug Development: From Test Tube to Patient, John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/9780470682920.ch8

Author Information

  1. Department of Pharmacology and Therapeutics, National University of Ireland, Galway, Ireland

Publication History

  1. Published Online: 13 NOV 2009
  2. Published Print: 8 JAN 2010

ISBN Information

Print ISBN: 9780470519790

Online ISBN: 9780470682920

SEARCH

Keywords:

  • preclinical and clinical safety evaluation;
  • safety concerns - emerging with experience of existing CNS drugs in humans;
  • preclinical investigations (in vitro, ex vivo and in vivo);
  • safety and toxicity questions - to be answered in drug development;
  • preclinical exploratory toxicology and safety pharmacology evaluations;
  • primary targets for CNS drugs and primary and secondary pharmacology;
  • safety pharmacology - satisfying need to identify alterations in organ functions;
  • toxicology studies for regulatory purposes;
  • assay systems in evaluating genotoxicity;
  • toxicity biomarker search

Summary

This chapter contains sections titled:

  • Introduction

  • Preclinical exploratory toxicology and safety pharmacology evaluations

  • Primary and secondary pharmacology

  • Safety pharmacology

  • Toxicology studies required for regulatory purposes

  • Clinical Studies

  • Specific drug profiles

  • Concluding comments

  • References

  • Websites