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This detailed book provides a compilation of laboratory techniques and tests to assess the risks to embryo-fetal development from drug exposure during early developmental stages. After an introduction to teratogenicity testing, the contents explore both in vitro and in vivo techniques in the study of the teratogenic and fetotoxic effects of drugs, as well as numerous animal-based teratology methods. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and comprehensive, Teratogenicity Testing: Methods and Protocols describes methods that integrate a battery of tests that can be performed in cells, organs, tissues, and animal models for evaluating toxicity and/or the safety of compounds in early developmental stages with the goal of estimating, preventing, or minimizing the teratogenic potential of drugs.
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 BiologyTM 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.
The evolution of toxicology testing finds its impetus in the continuing growth of the chemical and pharmaceutical industries, as well as the awareness of public health initiatives, needs, and responses that demand faster, more accurate, more economical methods for screening potential toxicity. Concurrent advances in biotechnology enable viable in v
The test substance is administered in graduated doses to several groups of males and females. Males should be dosed for a minimum of four weeks. Females should be dosed throughout the study, so approximately 54 days. This Test Guideline is designed ...
Nationally, toxicology programs have evolved from a traditional exploration of the chemistry and applied toxicity of chemicals and drugs to a more comprehensive study of toxicology and toxicology testing as independent entities. Consequently, the second edition of Principles of Toxicology Testing starts with basic toxicological principles, including absorption, distribution, metabolism, and elimination of toxins, including chemicals and drugs. The book then continues with animal (in vivo) and in vitro toxicology testing methods associated with toxicological analysis and preclinical drug development. As in the first edition, the book begins with an introduction into the fundamentals of toxicology (Section I) to prepare readers for the subsequent topics and continues through with a discussion of toxicokinetics and human risk assessment. This introductory material is useful in understanding the applications of toxicology testing. Section II describes the fundamental principles of toxicology testing in animals in greater detail. This section describes acute toxicity studies as well as subchronic and chronic studies performed on animals. Special emphasis is placed on study design and determination of classical indicators for acute and chronic testing, such as the LD50. The book examines other short- and long-term animal toxicity testing methodologies, including dermal, ocular, and reproductive toxicity testing. In addition, mutagenicity and carcinogenicity studies are also discussed in separate chapters. Section III introduces and discusses in vitro alternatives to animal toxicology tests. This section emphasizes cell culture methodology and cellular methods for acute systemic toxicity, target organ toxicity, and local toxicity. The contributors present the advantages and disadvantages of alternative methods. They also describe the use of high-throughput screening and its applications, the concepts of standardization and validation of in vitro techniques (especially large, organized validation efforts currently supported by US and EU regulatory agencies), and the theories supporting the development of in vitro methodologies. This second edition is a must-read for undergraduate and graduate toxicology students. Industrial and academic research centers will also find the text useful for establishing a toxicology testing laboratory.
Scientists agree that exposure to toxic agents in the environment can cause neurological and psychiatric illnesses ranging from headaches and depression to syndromes resembling parkinsonism. It can even result in death at high exposure levels. The emergence of subclinical neurotoxicity-the concept that long-term impairments can escape clinical detection-makes the need for risk assessment even more critical. This volume paves the way toward definitive solutions, presenting the current consensus on risk assessment and environmental toxicants and offering specific recommendations. The book covers: The biologic basis of neurotoxicity. Progress in the application of biologic markers. Reviews of a wide range of in vitro and in vivo testing techniques. The use of surveillance and epidemiology to identify neurotoxic hazards that escape premarket screening. Research needs. This volume will be an important resource for policymakers, health specialists, researchers, and students.
This book is an an up-to-date survey and summary of present knowledge and future expectations regarding the environmental causes of congenital malformations in human beings, beginning with the earliest discoveries of the 20th century up to the latest ideas and problems at its end, presents views and comments on the progress made over the century in understanding human prenatal maldevelopment.
In the fifteen years since the thalidomide disaster teratology has become a science in its own right, distinct from its progenitors, experimental embryology and develop mental biology, but bearing many of the familiar features of both parents. In this growth period there have been contributions from many different scientific disciplines as diverse as molecular biology and obstetrics, which have united in the field of study of congenital malformations. Scientists in academic departments, government research institutes and industrial pharmacology have all explored ways of evaluating the potential of drugs and chem icals to damage the embryo; strict methods of screening for teratogenicity have be come mandatory in most parts of the world. Despite a wealth of basic information in the fields of genetics and embryology, there is little concrete knowledge of the causal mechanisms of malformation in Man, and even less concerning the relevance to Man of those laboratory and animal tests which decide the fate of potentially useful drugs. It is timely, therefore, that in 1975 a group of young and active sci entists and clinicians concerned with the broader implications of teratology should review the past and look to the future of this emerging speciality. In this volume the editors have blended the opinions of teratologists; their message presages change in many of the old and accepted areas of investigative teratology.