Teratogenicity Testing: Methods and Protocols

ISBN-13: 9781627031301 / Angielski / Twarda / 2012 / 601 str.

Paul C. Barrow

Opis

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.

Spis treści

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 REACH

Steve 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