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Teratogenicity Testing

Methods and Protocols

  • Book
  • © 2013

Overview

Editors:
  1. Paul C. Barrow

    1. CiToxLAB, Evreux, France

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  • Provides extensive tips and guidance on how to deal with unexpected results and how to overcome difficulties
  • Features clear, complete instructions with each method
  • Serves as a comprehensive guide to methods of safety testing of all classes of chemical for teratogenicity
  • Includes supplementary material: sn.pub/extras

Part of the book series: Methods in Molecular Biology (MIMB, volume 947)

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Table of contents (36 protocols)

  1. Front Matter

    Pages i-xiv
    Download chapter PDF

  2. The ICH S5(R2) Guideline for the Testing of Medicinal Agents

    • L. David Wise
    Pages 1-11

  3. Nonclinical Reproductive Toxicity Testing Requirements for Drugs, Pesticides, and Industrial Chemicals in India and China

    • K. S. Rao, Jing Dong
    Pages 13-30

  4. The Developmental Toxicity Testing of Biologics

    • Keith P. Hazelden
    Pages 31-36

  5. The OECD Guidelines for the Testing of Chemicals and Pesticides

    • Jochen Buschmann
    Pages 37-56

  6. Teratology Testing Under REACH

    • Steve Barton
    Pages 57-72

  7. The Teratology Testing of Food Additives

    • Paul C. Barrow, François Spézia
    Pages 73-80

  8. Developmental Toxicity Testing of Vaccines

    • Paul C. Barrow, Linda Allais
    Pages 81-89

  9. The Teratology Testing of Cosmetics

    • François Spézia, Paul C. Barrow
    Pages 91-94

  10. Teratology Studies in the Rat

    • Mariline Leroy, Linda Allais
    Pages 95-109

  11. Teratology Studies in the Mouse

    • Edward Marsden, Mariline Leroy
    Pages 111-123

  12. Combined Fertility and Embryotoxicity Study

    • Lucie Reynaud, Edward Marsden
    Pages 125-137

  13. Teratology Studies in the Rabbit

    • Linda Allais, Lucie Reynaud
    Pages 139-156

  14. Teratology Studies in the Minipig

    • Peter A. McAnulty
    Pages 157-167

  15. Embryo fetal Development Studies in Nonhuman Primates

    • Antje Fuchs, Eberhard Buse, Gerhard F. Weinbauer
    Pages 169-183

  16. The Enhanced Pre- and Postnatal Development Study for Monoclonal Antibodies

    • Gerhard F. Weinbauer, Joerg Luft, Antje Fuchs
    Pages 185-200

  17. Skeletal Examination by Alizarin Staining

    • Lucie Reynaud, Audrey Jocteur-Monrozier
    Pages 201-213

  18. Skeletal Examination by Double Staining for Ossified Bone and Cartilaginous Tissue

    • Steffen Schneider
    Pages 215-221

  19. Small Animal Imaging and Examination by Micro-CT

    • Sergio X. Vasquez, Neha Shah, Alan M. Hoberman
    Pages 223-231

  20. Fetal Soft Tissue Examination by Serial Sectioning

    • Karon Critchell
    Pages 233-242
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Keywords

About this book

Teratology is the study of chemical-induced birth defects. This book is a comprehensive guide to the procedures and methods commonly employed in the safety testing of all classes of chemical for teratogenicity (also referred to as embryotoxicity, developmental toxicity or prenatal toxicity). The various international regulatory requirements are explained in detail, in order that the reader may perform all of the necessary studies for the successful registration or marketing authorisation of a new pharmaceutical, industrial chemical, crop protection product or food additive. Written in the highly successful Methods in Molecular Biology™ series format, each chapter gives clear complete instructions on how to perform the task in hand. The authors are respected experts in their field, all with hands-on experience of the procedures described. Teratogenicity Testing: Methods and Protocols gives crucial guidance and tips on how to deal with unexpected results and overcome regulatory difficulties.

Editors and Affiliations

  • CiToxLAB, Evreux, France

    Paul C. Barrow

Bibliographic Information

  • Book Title: Teratogenicity Testing

  • Book Subtitle: Methods and Protocols

  • Editors: Paul C. Barrow

  • Series Title: Methods in Molecular Biology

  • DOI: https://doi.org/10.1007/978-1-62703-131-8

  • Publisher: Humana Totowa, NJ

  • eBook Packages: Springer Protocols

  • Copyright Information: Springer Science+Business Media, LLC 2013

  • Hardcover ISBN: 978-1-62703-130-1Published: 09 November 2012

  • Softcover ISBN: 978-1-4939-6250-1Published: 23 August 2016

  • eBook ISBN: 978-1-62703-131-8Published: 09 November 2012

  • Series ISSN: 1064-3745

  • Series E-ISSN: 1940-6029

  • Edition Number: 1

  • Number of Pages: XIV, 601

  • Topics: Pharmacology/Toxicology

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