13. Toxicological and Pre-Clinical Considerations for Novel Excipients and New Chemical Entities

  1. Heather A. E. Benson2 and
  2. Adam C. Watkinson3
  1. Andrew Makin and
  2. Jens Thing Mortensen

Published Online: 3 JAN 2012

DOI: 10.1002/9781118140505.ch13

Transdermal and Topical Drug Delivery: Principles and Practice

Transdermal and Topical Drug Delivery: Principles and Practice

How to Cite

Makin, A. and Mortensen, J. T. (2011) Toxicological and Pre-Clinical Considerations for Novel Excipients and New Chemical Entities, in Transdermal and Topical Drug Delivery: Principles and Practice (eds H. A. E. Benson and A. C. Watkinson), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9781118140505.ch13

Editor Information

  1. 2

    School of Pharmacy, CHIRI, Curtin University, Perth, Australia

  2. 3

    Storith Consulting Limited, Kent, UK

Author Information

  1. LAB Research, Lille Skensved, Denmark

Publication History

  1. Published Online: 3 JAN 2012
  2. Published Print: 7 DEC 2011

ISBN Information

Print ISBN: 9780470450291

Online ISBN: 9781118140505

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Keywords:

  • novel excipients and new chemical entities, toxicological of NCE;
  • safety pharmacology, photosafety, testing enough doses in dermal toxicology;
  • excipients and toxicological effects, and NCE standard testing programs

Summary

This chapter contains sections titled:

  • Introduction

  • General Toxicology

  • Genotoxicity

  • Carcinogenicity

  • Reproductive Toxicity

  • Safety Pharmacology

  • Local Skin Irritation

  • Allergic Skin Sensitization

  • Photosafety

  • Excipients

  • Life Cycle Management

  • Animal Models

  • Species Selection

  • Exposure

  • Practical Considerations

  • Suggestions for a Standard Testing Program for an NCE or Excipient Intended for Dermal Application

  • References