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Drug Safety Evaluation

Methods and Protocols

  • Book
  • © 2017

Overview

Editors:
  1. Jean-Charles Gautier

    1. Preclinical Safety, Sanofi, R&D, Vitry-sur-Seine, France

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  • Includes cutting-edge methods and protocols
  • Provides step-by-step detail essential for reproducible results
  • Contains key notes and implementation advice from the experts

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

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Table of contents (23 protocols)

  1. Investigative Toxicology

    1. Statistical Analysis of Quantitative RT-PCR Results

      • Richard Khan-Malek, Ying Wang
      Pages 281-296

    2. Evaluation of Mitochondrial Respiration in Cultured Rat Hepatocytes

      • Jean-Pierre Marchandeau, Gilles Labbe
      Pages 297-308

  2. Screening Assays for Developmental Toxicity

    1. Front Matter

      Pages 309-309
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    2. FETAX Assay for Evaluation of Developmental Toxicity

      • Isabelle Mouche, Laure Malésic, Olivier Gillardeaux
      Pages 311-324

    3. Evaluation of Embryotoxicity Using the Zebrafish Model

      • Lisa Truong, Robert L. Tanguay
      Pages 325-333

  3. Safety Biomarkers

    1. Front Matter

      Pages 335-335
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    2. Absolute Quantification of Toxicological Biomarkers via Mass Spectrometry

      • Thomas Y. K. Lau, Ben C. Collins, Peter Stone, Ning Tang, William M. Gallagher, Stephen R. Pennington
      Pages 337-348

    3. Next-Generation Sequencing to Investigate Urinary microRNAs from Macaca fascicularis (Cynomolgus Monkey)

      • Yaligara Veeranagouda, Jean-François Léonard, Jean-Charles Gautier, Eric Boitier
      Pages 349-378

    4. Quantitative RT-PCR for MicroRNAs in Biofluids

      • Michael Thorsen, Thorarinn Blondal, Peter Mouritzen
      Pages 379-398

    5. Chromogenic In Situ Hybridization Methods for microRNA Biomarker Monitoring of Drug Safety and Efficacy

      • Barbara R. Gould, Tina Damgaard, Boye Schnack Nielsen
      Pages 399-412

    6. Urine Exosome Isolation and Characterization

      • Jonathan M. Street, Erik H. Koritzinsky, Deonna M. Glispie, Peter S. T. Yuen
      Pages 413-423

  4. Back Matter

    Pages 425-427
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Keywords

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.

Editors and Affiliations

  • Preclinical Safety, Sanofi, R&D, 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/10.1007/978-1-4939-7172-5

  • Publisher: Humana New York, NY

  • eBook Packages: Springer Protocols

  • Copyright Information: Springer Science+Business Media LLC 2017

  • Hardcover ISBN: 978-1-4939-7170-1Published: 27 July 2017

  • Softcover ISBN: 978-1-4939-8406-0Published: 08 August 2018

  • eBook ISBN: 978-1-4939-7172-5Published: 25 July 2017

  • Series ISSN: 1064-3745

  • Series E-ISSN: 1940-6029

  • Edition Number: 2

  • Number of Pages: XI, 427

  • Number of Illustrations: 30 b/w illustrations, 28 illustrations in colour

  • Topics: Pharmacology/Toxicology

  • Industry Sectors: Biotechnology, Chemical Manufacturing, Consumer Packaged Goods, Health & Hospitals, Pharma

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