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.
Table of Contents
PRINCIPLES AND MECHANISMS
Principles of Developmental Toxicology Revisited, R.D. Hood
Experimental Approaches to Evaluate Mechanisms of Developmental Toxicity, E.M. Faustman, J.M. Gohlke, R.A. Ponce, T.A. Lewandowski, M.R. Seeley, S.G. Whittaker, and W.C. Griffith
Pathogenesis of Abnormal Development, L.B. Fawcett and R.L. Brent
Maternally-Mediated Effects on Development, R.D. Hood and D.B. Miller
Paternally-Mediated Effects on Development, B.F. Hales and B. Robaire
Comparative Features of Vertebrate Embryology, J.M. DeSesso
HAZARD AND RISK ASSESSMENT AND REGULATORY GUIDANCE
Developmental Toxicity Testing - Methodology, R.W. Tyl and M.C. Marr
Nonclinical Juvenile Toxicity Testing, M.J. Beck, E.L. Padgett, C.J. Bowman, D.T. Wilson, L.E. Kaufman, B.J. Varsho, D.G. Stump, M.D. Nemec, and J.F. Holson
Significance, Reliability, and Interpretation of Developmental and Reproductive Toxicity Study Findings, J. Holson, M.D. Nemec, D.G. Stump, L.E. Kaufman, P. Lindström, and B.J. Varsho
Testing for Reproductive Toxicity, R.M. Parker
The U.S. EPA Endocrine Disruptor Screening Program: In Vitro and In Vivo Mammalian Tier I Screening Assays, S.C. Laws, T.E. Stoker, J.M. Goldman, V. Wilson, L.E. Gray, Jr., and R.L. Cooper
Role of Xenobiotic Metabolism in Developmental and Reproductive Toxicity, A.P. Kulkarni
Use of Toxicokinetics in Developmental and Reproductive Toxicology, P.J. Wier
Cellular, Biochemical, and Molecular Techniques in Developmental Toxicology, B.D. Abbott, M.B. Rosen, and G. Held
Functional Genomics and Proteomics in Developmental and Reproductive Toxicology, O. Spiegelstein, R.M. Cabrera, and R.H. Finnell
In Vitro Methods for the Study of Mechanisms of Developmental Toxicology, C. Harris and J.M. Hansen
Statistical Analysis for Developmental and Reproductive Toxicologists, J.J. Chen
Quality Concerns for Developmental and Reproductive Toxicologists, K.D. Barrowclough and K.L. Reed
Perspectives on the Developmental and Reproductive Toxicity Guidelines, M.S. Christian, A.M. Hoberman, and E.M. Lewis
Human Studies - Epidemiologic Techniques in Developmental and Reproductive Toxicology, B. Källén
Developmental and Reproductive Toxicity Risk Assessment for Environmental Agents, C.A. Kimmel, G.L. Kimmel, and S.Y. Euling
Principles of Risk Assessment-FDA Perspective, T.F.X. Collins, R.L. Sprando, M.E. Shackelford, M.F. Gruber, and D.E. Morse
A. Terminology of Anatomical Defects
B. Books Related to Developmental and Reproductive Toxicology
C. Postnatal Developmental Milestones
Ronald D. Hood is a Toxicology Consultant at Ronald D. Hood & Associates and works at the University of Alabama, Tuscaloosa, USA.
"This is a great foundation book for trainees pursuing research in reproductive toxicology and serves as the perfect reference during the course of study. The field of reproductive toxicology is changing and this update is critical and mostly timely."
—Doody's Review Service
"It is one of the most comprehensive and definitive publications in the field and should be a mandatory addition to the libraries of students, researchers, and regulators alike in the field of reproductive and developmental toxicology."
—International Journal of Toxicology