Hood Ronald D. (ed.) Developmental and Reproductive Toxicology: A Practical Approach

3rd edition. — Informa Healthcare, 2012. — 872 p. — ISBN: 9781841847771The purpose of this third edition of Developmental and Reproductive Toxicology is to provide a practical guide to developmental and reproductive toxicology in a regulatory environment. In addition to a comprehensive update of current chapters, the third edition been revised to reflect recent changes in the field. It contains new chapters that reflect emerging topics of interest, including testing of biologics (including vaccines), nonhuman primates as nonclinical models, developmental immunotoxicity testing, in vitro assays (such as use of zebrafish and stem cells, as well as high throughput screening), in silico systems modelling, evaluating mechanisms of reproductive toxicity, in-depth coverage of neurobehavioral testing, and testing under the EU’s REACH regulations, as well as updated chapters on nonclinical juvenile toxicity testing, endocrine disruptor screening, and on functional and computational genomics.The study of hazard and risk associated with exposure to toxicants during prenatal development has been expanded in recent years to include effects on development until the time of puberty. Concern over the adverse effects of chemical or physical agents on the reproductive processes of both sexes has increased, and progress has been made in identifying the causes and mechanisms eliciting congenital defects and determining the genetic, epigenetic, and environmental factors involved. This book provides up-to-date guidance on the use and interpretation of the newest research techniques in developmental and reproductive toxicology, as well as the more traditional approaches.Principles and Mechanisms
Principles of developmental toxicology revisited
Experimental approaches to evaluate mechanisms of developmental toxicity
Experimental approaches to evaluate mechanisms of reproductive toxicity
Maternally-mediated effects on development
Paternally-mediated effects on development
Comparative gestational milestones in vertebrate development
Testing Principles and Methodology
Developmental toxicity testing—Methodology
Reproductive toxicity testing—Methodology
Significance, reliability, and interpretation of developmental and reproductive toxicity study findings
Nonclinical juvenile toxicity testing
Neurobehavioral testing for developmental toxicity
The U.S. EPA Endocrine Disruptor Screening Program: The Tier 1 Screening Battery
In vitro screening methods for developmental toxicology
Approaches for evaluation of mode of action
Functional genomics and proteomics in developmental and reproductive toxicology
Nonhuman primates as preclinical models for developmental and reproductive toxicity evaluation
Developmental and reproductive safety assessment of biopharmaceuticals
Developmental immunotoxicity testing
Developmental and reproductive safety testing of vaccines
Use of toxicokinetics in developmental and reproductive toxicology
Understanding statistics in developmental and reproductive toxicology
Quality concerns for reproduction and developmental toxicology studies
Predictive modeling and computational toxicology
Critical evaluation of current developmental toxicity testing strategies—A case of babies and their bathwater
Risk Assessment and Regulatory Guidance
Perspectives on the developmental and reproductive toxicity guidelines
Human studies—Epidemiologic techniques in developmental and reproductive toxicology
Developmental and reproductive toxicity risk assessment for environmental agents
Perspectives in risk assessment—Drug and vaccine safety
Developmental and reproductive toxicity evaluation under the European Union REACH regulations