Developmental and Reproductive Toxicology 3rd Edition

Features

• Reproduces US and international regulatory guidelines and supplies agency-specific guidance from the U.S. FDA and EPA
• Provides up-to-date guidance on use and interpretation of the newest research techniques, such as functional genomics and proteomics, as well as traditional approaches
• Supplies guidance for conducting tests and interpreting data in areas such as nonclinical juvenile toxicity testing, endocrine modulation, and toxicokinetics
• Presents extensive and detailed descriptions of how to conduct and evaluate virtually all types of studies in the fields of developmental and reproductive toxicology
• Provides material on postnatal developmental milestones and extensive glossaries of developmental defect terminology
• Includes an extensive and authoritative chapter on human studies -- epidemiologic techniques in developmental and reproductive toxicology

Summary

The 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.

Developmental and Reproductive Toxicology, Third Edition:

• Contains valuable insights gained from hands-on experience, together with a critical evaluation of current testing strategies.
• Includes guidance for the design, conduct, and interpretation of tests in all areas of developmental and reproductive toxicity.
• Contains reprinted guidelines from major regulatory agencies, as well as terminology for description of developmental abnormalities in laboratory animals, for easy reference.
• Provides guidance for planning and conducting preclinical toxicity studies and follow-up studies, and interpreting their results in a regulatory environment.

This book continues to be the ideal practical reference for developmental and reproductive toxicologists who perform research in industry, government, and academia and for anyone who intends to enter these research areas.