Teratogenicity Testing -

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Résumé :
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.

Sommaire:
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 Fran?ois Spezia?7. Developmental Toxicity Testing of VaccinesPaul Barrow and Linda Allais?8. The Tratology Testing of CosmeticsFran?ois Sp?zia 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