Teratogenicity Testing: Methods and Protocols

Overview

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, ...

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Overview

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 Prools gives crucial guidance and tips on how to deal with unexpected results and overcome regulatory difficulties.

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Product Details

  • ISBN-13: 9781627031301
  • Publisher: Springer-Verlag New York, LLC
  • Publication date: 11/9/2012
  • Series: Methods in Molecular Biology Series, #947
  • Edition description: 2013
  • Edition number: 1
  • Pages: 601
  • Product dimensions: 7.10 (w) x 10.20 (h) x 1.50 (d)

Table of Contents

1. The ICH S5(R2) Guideline for the Testing of Medicinal Agents
L. David Wise

2. Non-Clinical Reproductive Toxicity Testing Requirements for Drugs, Pesticides, and Industrial Chemicals in India and China
K.S. Rao and Jing Dong

3. The Developmental Toxicity Testing of Biologics
Keith P Hazelden

4. The OECD Guidelines for the Testing of Chemicals and Pesticides
Jochen Buschmann
5. Teratology Testing Under REACHSteve Barton

6. The Teratology Testing of Food Additives
Paul Barrow and François Spezia

7. Developmental Toxicity Testing of Vaccines
Paul Barrow and Linda Allais

8. The Tratology Testing of Cosmetics
François Spézia and Paul Barrow

9. Teratology Studies in the Rat
Mariline Leroy and Linda Allais

10. Teratology Studies in the Mouse
Edward Marsden and Mariline Leroy

11. Combined Fertility and Embryotoxicity Study
Lucie Reynaud and Edward Marsden

12.Teratology Studies in the Rabbit
Linda Allais and Lucie Reynaud

13. Teratology Studies in the Minipig
Peter A. McAnulty

14. Embryofetal Development Studies in Nonhuman Primates
Antje Fuchs, Eberhard Buse, Gerhard F. Weinbauer

15. The Enhanced Pre- and Post-natal Development Study for Monoclonal Antibodies
Gerhard F Weinbauer, Joerg Luft, and Antje Fuchs

16. Skeletal Examination by Alizarin Staining
Lucie Reynaud and Audrey Jocteur-Monrozier

17. Skeletal Examination by Double Staining for Ossified Bone and Cartilaginous Tissue
Steffen Schneider

18. Small Animal Imaging and Examination by Micro-CT
Sergio X. Vasquez, Neha Shah, Alan M. Hoberman

19. Fetal Soft Tissue Examination by Serial Sectioning
Karon Critchell Huntingdon

20. Fetal Soft Tissue Examinations by Microdissection
Mariline Leroy and Audrey Jocteur Monrozier

21. Soft Tissue Examination Of The Fetal Rat And Rabbit Head By Magnetic Resonance Imaging
Julian M French and Neil Woodhouse

22. Historical Control Data in Reproductive and Developmental Toxicity Studies
Eve Mylchreest

23. Reporting of Teratology Studies
Paul Barrow and Lucie Reynaud

24. Maternal Toxicity
Bengt R Danielsson

25. Innovations in Testing Strategies in Reproductive Toxicology
Aldert H. Piersma

26. Predictive Models and Computational Toxicology
Thomas Knudsen, Matthew Martin, Kelly Chandler, Nicole Kleinstreuer, Richard Judson, and Nisha Sipes

27. The Embryonic Stem Cell Test
Sjors H.W. Schulpen and Aldert H. Piersma

28. Zebrafish Teratogenicity Testing
Kimberly C. Brannen, Jeffrey H. Charlap, and Elise M. Lewis

29. Frog Embryo Teratogenesis Assay on Xenopus (FETAX) and Predictivity Compared with In-vivo Mammalian Studies
I. Leconte and I. Mouche

30. The Rat Whole Embryo Culture Assay using the Dysmorphology Score System
Cindy Zhang, Julie Panzica-Kelly, Karen Augustine-Rauch

31. Toxicogenomic Approaches in Developmental Toxicology Testing
Joshua F. Robinson­ and Aldert H. Piersma

32. Validation of Alternative Tests for Developmental and Reproductive Toxicology Testing – An ILSI Health and Environmental Sciences Institute Perspective
James H. Kim

33. Regulatory Assessment of Reproductive Toxicology Data
Elizabeth Davidson

34. Hazard and Risk Assessment of Teratogenic Chemicals under REACH
Wiebke Prutner

35. Reproductive Toxicity Risk Assessment for Pesticides
Beate Ulbrich
36. The Thalidomide Disaster, Lessons from the Past
James E Ridings

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