Drug Safety Evaluation

Methods and Protocols

  • Jean-Charles Gautier

Part of the Methods in Molecular Biology book series (MIMB, volume 1641)

Table of contents

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

    1. Front Matter
      Pages 1-1
  3. Pathology

    1. Front Matter
      Pages 69-69
    2. Laurence Fiette, Mohamed Slaoui, Anne-Laure Bauchet
      Pages 71-100
    3. Mohamed Slaoui, Anne-Laure Bauchet, Laurence Fiette
      Pages 101-114
    4. José A. Ramos-Vara
      Pages 115-128
    5. David Bonnel, Jonathan Stauber
      Pages 129-140
  4. Genetic Toxicology

  5. Safety Pharmacology

    1. Front Matter
      Pages 185-185
    2. Sylvie Houtmann, Brigitte Schombert, Camille Sanson, Michel Partiseti, G. Andrees Bohme
      Pages 187-199
  6. Investigative Toxicology

    1. Front Matter
      Pages 211-211
    2. Richard J. Brennan
      Pages 213-228
    3. Alexander Amberg, Björn Riefke, Götz Schlotterbeck, Alfred Ross, Hans Senn, Frank Dieterle et al.
      Pages 229-258
    4. Richard Khan-Malek, Ying Wang
      Pages 281-296
    5. Jean-Pierre Marchandeau, Gilles Labbe
      Pages 297-308
  7. Screening Assays for Developmental Toxicity

    1. Front Matter
      Pages 309-309
    2. Isabelle Mouche, Laure Malésic, Olivier Gillardeaux
      Pages 311-324
    3. Lisa Truong, Robert L. Tanguay
      Pages 325-333
  8. Safety Biomarkers

    1. Front Matter
      Pages 335-335
    2. Thomas Y. K. Lau, Ben C. Collins, Peter Stone, Ning Tang, William M. Gallagher, Stephen R. Pennington
      Pages 337-348
    3. Yaligara Veeranagouda, Jean-François Léonard, Jean-Charles Gautier, Eric Boitier
      Pages 349-378
    4. Michael Thorsen, Thorarinn Blondal, Peter Mouritzen
      Pages 379-398
    5. Barbara R. Gould, Tina Damgaard, Boye Schnack Nielsen
      Pages 399-412
    6. Jonathan M. Street, Erik H. Koritzinsky, Deonna M. Glispie, Peter S. T. Yuen
      Pages 413-423
  9. Back Matter
    Pages 425-427

About this book


This second edition provides up-to-date chapters and new chapters focusing on the most recent advances in the field of drug safety evaluation. Divided into seven parts, chapters detail specific aspects related to the experimental design of preclinical studies conducted to support the safety of pediatric and combination drugs, necropsy and histopathology evaluation, mass spectrometry imaging, genetic toxicology protocols including the Pig-a mutation assay, safety pharmacology methods such as automatization of patch-clamp procedures, target safety assessment for investigative toxicology, screening assays for developmental toxicology, and methods to characterize novel translational safety biomarkers like microRNAs. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting to avoid known pitfalls.

Authoritative and practical, Drug Safety Evaluation: Methods and Protocols, Second Edition aims to ensure successful results in the further study of this vital field.


immunohistochemistry mass spectrometry imaging histopathology evaluation Pig-a mutation patch-clamp procedures necropsy investigative toxicology

Editors and affiliations

  • Jean-Charles Gautier
    • 1
  1. 1.Preclinical SafetySanofi, R&DVitry-sur-SeineFrance

Bibliographic information

  • DOI
  • Copyright Information Springer Science+Business Media LLC 2017
  • Publisher Name Humana Press, New York, NY
  • eBook Packages Springer Protocols
  • Print ISBN 978-1-4939-7170-1
  • Online ISBN 978-1-4939-7172-5
  • Series Print ISSN 1064-3745
  • Series Online ISSN 1940-6029
  • Buy this book on publisher's site