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Book Cover
E-book

Title Teratogenicity testing : methods and protocols / edited by Paul C. Barrow
Published New York : Humana Press : Springer, ©2013

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Description 1 online resource (xiv, 601 pages) : illustrations (some color)
Series Methods in molecular biology, 1940-6029 ; 947
Methods in molecular biology (Clifton, N.J.) ; v. 947. 1064-3745
Contents ICH S5(R2) guideline for the testing of medicinal agents / L. David Wise -- Nonclinical reproductive toxicity testing requirements for drugs, pesticides, and industrial chemicals in India and China / K.S. Rao and Jing Dong -- Developmental toxicity testing of biologics / Keith P. Hazelden -- OECD guidelines for the testing of chemicals and pesticides / Jochen Buschmann -- Teratology testing under REACH / Steve Barton -- Teratology testing of food additives / Paul C. Barrow and Francois Spezia -- Developmental toxicity testing of vaccines / Paul C. Barrow and Linda Allais -- Teratology testing of cosmetics / Francois Spezia and Paul C. Barrow -- Teratology studies in the rat / Mariline Leroy and Linda Allais -- Teratology studies in the mouse / Edward Marsden and Mariline Leroy -- Combined fertility and embryotoxicity study / Lucie Reynaud and Edward Marsden -- Teratology studies in the rabbit / Linda Allais and Lucie Reynaud -- Teratology studies in the minipig / Peter A. McAnulty -- Embryo fetal development studies in nonhuman primates / Antje Fuchs, Eberhard Buse, and Gerhard F. Weinbauer -- Enhanced pre- and postnatal development study for monoclonal antibodies / Gerhard F. Weinbauer, Joerg Luft, and Antje Fuchs -- Skeletal examination by alizarin staining / Lucie Reynaud and Audrey Jocteur-Monrozier -- Skeletal examination by double staining for ossified bone and cartilaginous tissue / Steffen Schneider -- Small snimal imaging and examination by micro-CT / Sergio X. Vasquez, Neha Shah, and Alan M. Hoberman -- Fetal soft tissue examination by serial sectioning / Karon Critchell -- Fetal soft tissue examinations by microdissection / Mariline Leroy and Audrey Jocteur-Monrozier -- Soft tissue examination of the fetal rat and rabbit head by magnetic resonance imaging. / Julian M. French and Neil Woodhouse -- Historical control data in reproductive and developmental toxicity studies / Eve Mylchreest and Stephen B. Harris -- Reporting of teratology studies / Paul C. Barrow and Lucie Reynaud -- Maternal toxicity / Bengt R. Danielsson -- Innovations in testing strategies in reproductive toxicology / Aldert H. Piersma -- Predictive models and computational toxicology / Thomas Knudsen [and others] -- Embryonic stem cell test / Sjors H.W. Schulpen and Aldert H. Piersma -- Zebrafish teratogenicity testing / Kimberly C. Brannen, Jeffrey H. Charlap, and Elise M. Lewis -- Frog embryo teratogenesis assay on Xenopus and predictivity compared with in vivo mammalian studies / Isabelle Leconte and Isabelle Mouche -- Rat whole embryo culture assay using the dysmorphology score system / Cindy Zhang, Julie Panzica-Kelly, and Karen Augustine-Rauch -- Toxicogenomic approaches in developmental toxicology testing / Joshua F. Robinson and Aldert H. Piersma -- Validation of alternative tests for developmental and reproductive toxicology testing : an ILSI Health and Environmental Sciences Institute perspective / James H. Kim -- Regulatory assessment of reproductive toxicology data / Elizabeth Davidson -- Hazard and risk assessment of teratogenic chemicals under REACH / Wiebke Prutner -- Reproductive toxicity risk assessment for pesticides / Beate Ulbrich -- Thalidomide disaster, lessons from the past / James E. Ridings
Summary 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
Analysis farmacologie
pharmacology
toxicologie
toxicology
biomedische wetenschappen
biomedicine
Medicine (General)
Geneeskunde (algemeen)
Bibliography Includes bibliographical references and index
Notes English
Print version record
Subject Teratogenicity testing -- Laboratory manuals
Teratogenic agents.
Teratogens
Teratogenic agents
Teratogenicity testing
Genre/Form Laboratory manuals
Laboratory manuals.
Manuels de laboratoire.
Form Electronic book
Author Barrow, Paul.
ISBN 9781627031318
1627031316