Teratogenicity Testing: Methods and Protocols (Methods in Molecular Biology, 947)

✍ Scribed by Paul C. Barrow (editor)

• Publisher: Humana
• Year: 2012
• Tongue: English
• Leaves: 596
• Category: Library

✦ Synopsis

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.

✦ Table of Contents

Teratogenicity Testing
Dedication
Preface
Contents
Contributors
Chapter 1: The ICH S5(R2) Guideline for the Testing of Medicinal Agents
Chapter 2: Nonclinical Reproductive Toxicity Testing Requirements for Drugs, Pesticides, and Industrial Chemicals in India and China
Chapter 3: The Developmental Toxicity Testing of Biologics
Chapter 4: The OECD Guidelines for the Testing of Chemicals and Pesticides
Chapter 5: Teratology Testing Under REACH
Chapter 6: The Teratology Testing of Food Additives
Chapter 7: Developmental Toxicity Testing of Vaccines
Chapter 8: The Teratology Testing of Cosmetics
Chapter 9: Teratology Studies in the Rat
Chapter 10: Teratology Studies in the Mouse
Chapter 11: Combined Fertility and Embryotoxicity Study
Chapter 12: Teratology Studies in the Rabbit
Chapter 13: Teratology Studies in the Minipig
Chapter 14: Embryo fetal Development Studies in Nonhuman Primates
Chapter 15: The Enhanced Pre- and Postnatal Development Study for Monoclonal Antibodies
Chapter 16: Skeletal Examination by Alizarin Staining
Chapter 17: Skeletal Examination by Double Staining for Ossi fi ed Bone and Cartilaginous Tissue
Chapter 18: Small Animal Imaging and Examination by Micro-CT
Chapter 19: Fetal Soft Tissue Examination by Serial Sectioning
Chapter 20: Fetal Soft Tissue Examinations by Microdissection
Chapter 21: Soft Tissue Examination of the Fetal Rat and Rabbit Head by Magnetic Resonance Imaging
Chapter 22: Historical Control Data in Reproductive and Developmental Toxicity Studies
Chapter 23: Reporting of Teratology Studies
Chapter 24: Maternal Toxicity
Chapter 25: Innovations in Testing Strategies in Reproductive Toxicology
Chapter 26: Predictive Models and Computational Toxicology
Chapter 27: The Embryonic Stem Cell Test
Chapter 28: Zebra fi sh Teratogenicity Testing
Chapter 29: Frog Embryo Teratogenesis Assay on Xenopus and Predictivity Compared with In Vivo Mammalian Studies
Chapter 30: The Rat Whole Embryo Culture Assay Using the Dysmorphology Score System
Chapter 31: Toxicogenomic Approaches in Developmental Toxicology Testing
Chapter 32: Validation of Alternative Tests for Developmental and Reproductive Toxicology Testing: An ILSI Health and Environmental Sciences Institute Perspective
Chapter 33: Regulatory Assessment of Reproductive Toxicology Data
Chapter 34: Hazard and Risk Assessment of Teratogenic Chemicals Under REACH
Chapter 35: Reproductive Toxicity Risk Assessment for Pesticides
Chapter 36: The Thalidomide Disaster, Lessons from the Past
INDEX