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Drug Safety Evaluation

Methods and Protocols

  • Book
  • © 2011

Overview

Editors:
  1. Jean-Charles Gautier

    1. , Toxicologie Cellulaire et Moléculaire, Sanofi-aventis, Vitry-sur-Seine, France

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  • Features a compendium of analytical technologies, including some review chapters, with a focus on clarity and applicability in real life laboratory practice
  • Contains methods and techiques easily translated to a myriad of scientific disciplines
  • Presents key tips from the experts on the best way to conduct these techniques succesfully
  • Includes supplementary material: sn.pub/extras

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

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Table of contents (25 protocols)

  1. Front Matter

    Pages i-xiii
    Download chapter PDF

  2. General Toxicology

    1. Front Matter

      Pages 1-1
      Download chapter PDF

    2. Developing Combination Drugs in Preclinical Studies

      • Alberto Lodola
      Pages 3-16

    3. Preclinical Evaluation of Juvenile Toxicity

      • Paul C. Barrow, Stéphane Barbellion, Jeanne Stadler
      Pages 17-35

  3. Pathology

    1. Front Matter

      Pages 37-37
      Download chapter PDF

    2. Necropsy and Sampling Procedures in Rodents

      • Laurence Fiette, Mohamed Slaoui
      Pages 39-67

    3. Histopathology Procedures: From Tissue Sampling to Histopathological Evaluation

      • Mohamed Slaoui, Laurence Fiette
      Pages 69-82

    4. Principles and Methods of Immunohistochemistry

      • José A. Ramos-Vara
      Pages 83-96

    5. Tissue Microarrays and Digital Image Analysis

      • Denise Ryan, Laoighse Mulrane, Elton Rexhepaj, William M. Gallagher
      Pages 97-112

  4. Genetic Toxicology

    1. Front Matter

      Pages 113-113
      Download chapter PDF

    2. Micronucleus Assay and Labeling of Centromeres with FISH Technique

      • Ilse Decordier, Raluca Mateuca, Micheline Kirsch-Volders
      Pages 115-136

    3. The Use of Bacterial Repair Endonucleases in the Comet Assay

      • Andrew R. Collins
      Pages 137-147

  5. Safety Pharmacology

    1. Front Matter

      Pages 149-149
      Download chapter PDF

    2. Manual Whole-Cell Patch-Clamping of the HERG Cardiac K+ Channel

      • Xiao-Liang Chen, Jiesheng Kang, David Rampe
      Pages 151-163

  6. Investigative Toxicology

    1. Front Matter

      Pages 165-165
      Download chapter PDF

  7. Generation and Analysis of Transcriptomics Data

    1. Generation and Analysis of Transcriptomics Data

      • Philip D. Glaves, Jonathan D. Tugwood
      Pages 167-185

    2. Protocols of Two-Dimensional Difference Gel Electrophoresis to Investigate Mechanisms of Toxicity

      • Emmanuelle Com, Albrecht Gruhler, Martine Courcol, Jean-Charles Gautier
      Pages 187-203

    3. Protocols and Applications of Cellular Metabolomics in Safety Studies Using Precision-Cut Tissue Slices and Carbon 13 NMR

      • Gabriel Baverel, Sophie Renault, Hassan Faiz, Maha El Hage, Catherine Gauthier, Agnès Duplany et al.
      Pages 205-225

    4. Statistical Analysis of Quantitative RT-PCR Results

      • Richard Khan-Malek, Ying Wang
      Pages 227-241

    5. Evaluation of Mitochondrial Respiration in Cultured Rat Hepatocytes

      • Jean-Pierre Marchandeau, Gilles Labbe
      Pages 243-253
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Keywords

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.

Reviews

From the reviews:

“Describes in detail the standard, analytical methodologies that are used to evaluate the safety of a new compound or a particular compound’s use in a vulnerable patient population. … This is intended to serve as a resource for a variety of basic science researchers, as well as anyone interested in the methods used in evaluating drug safety in a preclinical setting. … This a very technical overview of the standard laboratory procedures and protocols used in the preclinical evaluation of drug safety.” (Rachel R. Chennault, Doody’s Review Service, April, 2011)

Editors and Affiliations

  • , Toxicologie Cellulaire et Moléculaire, Sanofi-aventis, Vitry-sur-Seine, France

    Jean-Charles Gautier

Bibliographic Information

  • Book Title: Drug Safety Evaluation

  • Book Subtitle: Methods and Protocols

  • Editors: Jean-Charles Gautier

  • Series Title: Methods in Molecular Biology

  • DOI: https://doi.org/10.1007/978-1-60761-849-2

  • Publisher: Humana Totowa, NJ

  • eBook Packages: Springer Protocols

  • Copyright Information: Springer Science+Business Media, LLC 2011

  • Hardcover ISBN: 978-1-60327-186-8Published: 26 October 2010

  • Softcover ISBN: 978-1-4939-5669-2Published: 23 August 2016

  • eBook ISBN: 978-1-60761-849-2Published: 23 October 2010

  • Series ISSN: 1064-3745

  • Series E-ISSN: 1940-6029

  • Edition Number: 1

  • Number of Pages: XIII, 431

  • Topics: Pharmacology/Toxicology, Laboratory Medicine

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