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Genotoxicity and Carcinogenicity Testing of Pharmaceuticals

  • Michael J. Graziano
  • David Jacobson-Kram

Table of contents

  1. Front Matter
    Pages i-x
  2. Lidiya Stavitskaya, Jiri Aubrecht, Naomi L. Kruhlak
    Pages 13-34
  3. L. L. Custer, M. W. Powley
    Pages 35-54
  4. Peter Kasper, Lutz Müller
    Pages 55-74
  5. Patricia A. Escobar, Stephen D. Dertinger, Robert H. Heflich
    Pages 75-94
  6. James S. MacDonald, David Jacobson-Kram
    Pages 95-108
  7. Abigail Jacobs, Frank D. Sistare
    Pages 109-124
  8. Maggie Dempster, Kris Siezen, Bas ter Braak, Willem van den Brink, Annette Emerenciana, Francesco Bellanti et al.
    Pages 125-157
  9. Todd Bourcier, Denis Roy
    Pages 159-182
  10. Lorrene A. Buckley, Beatriz Silva-Lima, Mark A. Tirmenstein
    Pages 183-203
  11. Back Matter
    Pages 205-206

About this book

Introduction

This book provides an overview of the nonclinical testing strategies that are used to asses and de-risk the genotoxicity and carcinogenicity properties of human pharmaceuticals. It includes a review of relevant ICH guidelines, numerous case studies where follow-up studies were conducted to further investigate positive findings, and practical considerations for the use of alternative and emerging tests.

With contributions from recognized experts in the pharmaceutical industry and health authorities, this volume presents a balanced view on the interpretation and application of genotoxicity and carcinogenicity regulatory guidances.  

Genotoxicity and Carcinogenicity Testing of Pharmaceuticals is a valuable resource for scientists, regulators, and consultants that are engaged in the conduct, reporting, and review of nonclinical studies. This book will also help academicians better understand and appreciate the complexity of the regulations and breadth of toxicology research that are necessary to support the development and marketing of new drugs.

Keywords

Carcinogenicity Genotoxicity Immunomodulators In Silico Predictive Tests Regulatory Tumor Signals

Editors and affiliations

  • Michael J. Graziano
    • 1
  • David Jacobson-Kram
    • 2
  1. 1.Vice- President of Drug Safety EvaluationBristol-Myers SquibbPrincetonUSA
  2. 2.ToxRox ConsultingMcLean VA 22101USA

Bibliographic information

Industry Sectors
Pharma
Biotechnology
Consumer Packaged Goods