Drug Safety Evaluation

Methods and Protocols

  • Jean-Charles Gautier

Part of the Methods in Molecular Biology book series (MIMB, volume 691)

Table of contents

  1. Front Matter
    Pages i-xiii
  2. General Toxicology

    1. Front Matter
      Pages 1-1
    2. Paul C. Barrow, Stéphane Barbellion, Jeanne Stadler
      Pages 17-35
  3. Pathology

    1. Front Matter
      Pages 37-37
    2. Laurence Fiette, Mohamed Slaoui
      Pages 39-67
    3. José A. Ramos-Vara
      Pages 83-96
    4. Denise Ryan, Laoighse Mulrane, Elton Rexhepaj, William M. Gallagher
      Pages 97-112
  4. Genetic Toxicology

    1. Front Matter
      Pages 113-113
    2. Ilse Decordier, Raluca Mateuca, Micheline Kirsch-Volders
      Pages 115-136
  5. Safety Pharmacology

    1. Front Matter
      Pages 149-149
    2. Xiao-Liang Chen, Jiesheng Kang, David Rampe
      Pages 151-163
  6. Investigative Toxicology

    1. Front Matter
      Pages 165-165
    2. Philip D. Glaves, Jonathan D. Tugwood
      Pages 167-185
    3. Emmanuelle Com, Albrecht Gruhler, Martine Courcol, Jean-Charles Gautier
      Pages 187-203
    4. Gabriel Baverel, Sophie Renault, Hassan Faiz, Maha El Hage, Catherine Gauthier, Agnès Duplany et al.
      Pages 205-225
    5. Richard Khan-Malek, Ying Wang
      Pages 227-241
    6. Jean-Pierre Marchandeau, Gilles Labbe
      Pages 243-253
  7. Screening Assays for Developmental Toxicity

    1. Front Matter
      Pages 255-255
    2. Isabelle Mouche, Laure Malesic, Olivier Gillardeaux
      Pages 257-269
    3. Lisa Truong, Stacey L. Harper, Robert L. Tanguay
      Pages 271-279
  8. Chemical Protein Adducts

    1. Front Matter
      Pages 281-281
    2. Jean-François Lévesque, Stephen H. Day, Allen N. Jones
      Pages 283-301
    3. Ashley A. Fisher, Matthew T. Labenski, Terrence J. Monks, Serrine S. Lau
      Pages 303-316
    4. Ashley A. Fisher, Matthew T. Labenski, Terrence J. Monks, Serrine S. Lau
      Pages 317-326
    5. Matthew T. Labenski, Ashley A. Fisher, Terrence J. Monks, Serrine S. Lau
      Pages 327-338
    6. Matthew T. Labenski, Ashley A. Fisher, Terrence J. Monks, Serrine S. Lau
      Pages 339-347
  9. Safety Biomarkers

    1. Front Matter
      Pages 349-349
    2. Jean-Francois Léonard, Martine Courcol, Jean-Charles Gautier
      Pages 351-368
    3. Ben C. Collins, Thomas Y. K. Lau, Stephen R. Pennington, William M. Gallagher
      Pages 369-383
    4. Frank Dieterle, Björn Riefke, Götz Schlotterbeck, Alfred Ross, Hans Senn, Alexander Amberg
      Pages 385-415
    5. Thomas Y. K. Lau, Ben C. Collins, Peter Stone, Ning Tang, William M. Gallagher, Stephen R. Pennington
      Pages 417-427
  10. Back Matter
    Pages 429-431

About this book


Non-clinical drug safety evaluation, the assessment of the safety profile of therapeutic agents through the conduct of laboratory studies in in vitro systems and in animals, is an essential step in the progress of new pharmaceuticals heading toward the ultimate goal of clinical trials and, eventually, approval. In Drug Safety Evaluation: Methods and Protocols, expert researchers detail a compendium of analytical technologies with a focus on clarity and applicability in real life laboratory practice. These meticulous contributions feature key topics such as acute to chronic general toxicity studies, histopathology studies, reproductive toxicity studies, genotoxicity studies, safety pharmacology studies, investigative toxicity studies, and safety biomarker studies. As a volume in the highly successful Methods in Molecular Biology™ series, chapters include brief introductions to their respective subjects, lists of the necessary materials, step-by-step, readily reproducible protocols, and tips on troubleshooting and avoiding known pitfalls. Comprehensive and authoritative, Drug Safety Evaluation: Methods and Protocols serves as an ideal guide to this field, helpful to pharmaceutical scientists, toxicologists, biochemists, and molecular biologists as well as scientists from all other disciplines who wish to translate these thorough methods into their own work.


Carcinogenicity Chemical protein adducts Developmental toxicity Experimental design General toxicity studies Genotoxicity Novel safety biomarkers Reproductive toxicology Safety pharmacology Screening assays Therapeutic agents

Editors and affiliations

  • Jean-Charles Gautier
    • 1
  1. 1., Toxicologie Cellulaire et MoléculaireSanofi-aventisVitry-sur-SeineFrance

Bibliographic information

  • DOI
  • Copyright Information Springer Science+Business Media, LLC 2011
  • Publisher Name Humana Press
  • eBook Packages Springer Protocols
  • Print ISBN 978-1-60327-186-8
  • Online ISBN 978-1-60761-849-2
  • Series Print ISSN 1064-3745
  • Series Online ISSN 1940-6029
  • Buy this book on publisher's site
Industry Sectors
Health & Hospitals
Pharmacology & Toxicology
Consumer Packaged Goods