6. Nonclinical Safety Pharmacology Studies Recommended for Support of First-in-Human Clinical Trials

  1. Mitchell N. Cayen
  1. Duane B. Lakings

Published Online: 3 AUG 2010

DOI: 10.1002/9780470613191.ch6

Early Drug Development

Early Drug Development

How to Cite

Lakings, D. B. (2010) Nonclinical Safety Pharmacology Studies Recommended for Support of First-in-Human Clinical Trials, in Early Drug Development (ed M. N. Cayen), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470613191.ch6

Editor Information

  1. Cayen Pharmaceutical Consulting, LLC, Bedminster, New Jersey, USA

Author Information

  1. DSE Consulting, Inc., Elgin, Texas, USA

Publication History

  1. Published Online: 3 AUG 2010
  2. Published Print: 23 JUL 2010

ISBN Information

Print ISBN: 9780470170861

Online ISBN: 9780470613191

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Keywords:

  • nonclinical safety pharmacology studies - support of first-in-human clinical trials;
  • CNS safety pharmacology - motor activity, behavioral changes, coordination, sensory/motor reflex responses and body temperature parameters;
  • respiratory system safety pharmacology - NCE effects on respiratory system

Summary

This chapter contains sections titled:

  • Introduction and Overview

  • Timing of Safety Pharmacology Studies

  • CNS Safety Pharmacology

  • Cardiovascular Safety Pharmacology

  • Respiratory System Safety Pharmacology

  • Renal/Urinary Safety Pharmacology

  • Gastrointestinal System Safety Pharmacology

  • Autonomic Nervous System Safety Pharmacology

  • Other Systems

  • Discussion and Conclusions

  • References