Teratogenicity Testing: Methods and Protocols by Paul C. BarrowTeratogenicity Testing: Methods and Protocols by Paul C. Barrow

Teratogenicity Testing: Methods and Protocols

EditorPaul C. Barrow

Hardcover | November 9, 2012

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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 BiologyT 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.
Title:Teratogenicity Testing: Methods and ProtocolsFormat:HardcoverDimensions:615 pagesPublished:November 9, 2012Publisher:Humana PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:1627031308

ISBN - 13:9781627031301

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Table of Contents

1. The ICH S5(R2) Guideline for the Testing of Medicinal AgentsL. David Wise 2. Non-Clinical Reproductive Toxicity Testing Requirements for Drugs, Pesticides, and Industrial Chemicals in India and ChinaK.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 PesticidesJochen Buschmann 5. Teratology Testing Under REACHSteve Barton 6. The Teratology Testing of Food AdditivesPaul Barrow and François Spezia 7. Developmental Toxicity Testing of VaccinesPaul Barrow and Linda Allais 8. The Tratology Testing of CosmeticsFrançois Spézia and Paul Barrow 9. Teratology Studies in the RatMariline Leroy and Linda Allais 10. Teratology Studies in the MouseEdward Marsden and Mariline Leroy 11. Combined Fertility and Embryotoxicity StudyLucie Reynaud and Edward Marsden 12.Teratology Studies in the RabbitLinda Allais and Lucie Reynaud 13. Teratology Studies in the MinipigPeter A. McAnulty 14. Embryofetal Development Studies in Nonhuman PrimatesAntje Fuchs, Eberhard Buse, Gerhard F. Weinbauer 15. The Enhanced Pre- and Post-natal Development Study for Monoclonal AntibodiesGerhard F Weinbauer, Joerg Luft, and Antje Fuchs 16. Skeletal Examination by Alizarin StainingLucie Reynaud and Audrey Jocteur-Monrozier 17. Skeletal Examination by Double Staining for Ossified Bone and Cartilaginous TissueSteffen Schneider 18. Small Animal Imaging and Examination by Micro-CTSergio X. Vasquez, Neha Shah, Alan M. Hoberman 19. Fetal Soft Tissue Examination by Serial SectioningKaron Critchell Huntingdon  20. Fetal Soft Tissue Examinations by MicrodissectionMariline Leroy and Audrey Jocteur Monrozier 21. Soft Tissue Examination Of The Fetal Rat And Rabbit Head By Magnetic Resonance ImagingJulian M French and Neil Woodhouse 22. Historical Control Data in Reproductive and Developmental Toxicity Studies Eve Mylchreest 23. Reporting of Teratology StudiesPaul Barrow and Lucie Reynaud 24. Maternal ToxicityBengt R Danielsson 25.   Innovations in Testing Strategies in Reproductive ToxicologyAldert H. Piersma 26. Predictive Models and Computational ToxicologyThomas Knudsen, Matthew Martin, Kelly Chandler, Nicole Kleinstreuer, Richard Judson, and Nisha Sipes 27. The Embryonic Stem Cell TestSjors H.W. Schulpen and Aldert H. Piersma 28. Zebrafish Teratogenicity TestingKimberly C. Brannen, Jeffrey H. Charlap, and Elise M. Lewis 29. Frog Embryo Teratogenesis Assay on Xenopus (FETAX) and Predictivity Compared with In-vivo Mammalian StudiesI. Leconte and I. Mouche 30. The Rat Whole Embryo Culture Assay using the Dysmorphology Score SystemCindy Zhang, Julie Panzica-Kelly, Karen Augustine-Rauch 31. Toxicogenomic Approaches in Developmental Toxicology TestingJoshua F. Robinson­ and Aldert H. Piersma 32. Validation of Alternative Tests for Developmental and Reproductive Toxicology Testing - An ILSI Health and Environmental Sciences Institute PerspectiveJames H. Kim 33. Regulatory Assessment of Reproductive Toxicology DataElizabeth Davidson 34. Hazard and Risk Assessment of Teratogenic Chemicals under REACHWiebke Prutner 35. Reproductive Toxicity Risk Assessment for PesticidesBeate Ulbrich 36. The Thalidomide Disaster, Lessons from the PastJames E Ridings