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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 Biology(TM) 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.
Table des matières
The ICH S5(R2) Guideline for the Testing of Medicinal Agents.-Non-Clinical Reproductive Toxicity Testing Requirements for Drugs, Pesticides, and Industrial Chemicals in India and China.-The Developmental Toxicity Testing of Biologics.-The OECD Guidelines for the Testing of Chemicals and Pesticides.-Teratology Testing Under REACH.-The Teratology Testing of Food Additives.-Developmental Toxicity Testing of Vaccines.-The Tratology Testing of Cosmetics.-Teratology Studies in the Rat.-Teratology Studies in the Mouse.-Combined Fertility and Embryotoxicity Study.-Teratology Studies in the Rabbit.-Teratology Studies in the Minipig.-Embryofetal Development Studies in Nonhuman Primates.-The Enhanced Pre- and Post-natal Development Study for Monoclonal Antibodies.-Skeletal Examination by Alizarin Staining.-Skeletal Examination by Double Staining for Ossified Bone and Cartilaginous Tissue.-Small Animal Imaging and Examination by Micro-CT.-Fetal Soft Tissue Examination by Serial Sectioning.-Fetal Soft Tissue Examinations by Microdissection.-Soft Tissue Examination Of The Fetal Rat And Rabbit Head By Magnetic Resonance Imaging.-Historical Control Data in Reproductive and Developmental Toxicity Studies.-Reporting of Teratology Studies.-Maternal Toxicity.-Innovations in Testing Strategies in Reproductive Toxicology.-Predictive Models and Computational Toxicology.-The Embryonic Stem Cell Test.-Zebrafish Teratogenicity Testing.-Frog Embryo Teratogenesis Assay on Xenopus (FETAX) and Predictivity Compared with In-vivo Mammalian Studies.-The Rat Whole Embryo Culture Assay using the Dysmorphology Score System.-Toxicogenomic Approaches in Developmental Toxicology Testing.-Validation of Alternative Tests for Developmental and Reproductive Toxicology Testing - An ILSI Health and Environmental Sciences Institute Perspective.-Regulatory Assessment of Reproductive Toxicology Data.-Hazard and Risk Assessment of Teratogenic Chemicals under REACH.-Reproductive Toxicity Risk Assessment for Pesticides.-The Thalidomide Disaster, Lessons from the Past.
Résumé
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.
