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MORE ABOUT THIS BOOK
Main description:
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.
Feature:
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
Back cover:
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.
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
PRODUCT DETAILS
Publisher: Springer (Humana Press)
Publication date: November, 2012
Pages: 616
Weight: 1339g
Availability: POD
Subcategories: Diseases and Disorders, Endocrinology, Pharmacology
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