[PDF] Teratogenicity Testing eBook

Author : Luís Félix
Publisher : Humana
Page : 614 pages
File Size : 46,55 MB
Release : 2019-06-27
Category : Medical
ISBN : 9781493993147

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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.

Author : Paul C. Barrow
Publisher : Humana Press
Page : 0 pages
File Size : 31,76 MB
Release : 2012-11-09
Category : Medical
ISBN : 9781627031301

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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.

Author : T.V.N. Persaud
Publisher : Springer Science & Business Media
Page : 357 pages
File Size : 29,71 MB
Release : 2012-12-06
Category : Science
ISBN : 940116651X

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The study of birth defects has assumed an importance even greater now than in the past because mortality rates attributed to congenital anomalies have declined far less than those for other causes of death, such as infectious and nutritional diseases. It is estimated that as many as 50% of all pregnancies terminate as miscarriages. In the majority of cases this is the result of faulty development. Major congenital malformations are found in at least 2% of all liveborn infants, and 22% of all stillbirths and infant deaths are associated with severe congenital anomalies. Teratological studies of an experimental nature are neither ethical nor justifiable in humans. Numerous investigations have been carried out in laboratory animals and other experimental models in order to improve our understanding of abnormal intra-uterine development. In less than two decades the field of experimental teratology has advanced phenomenally. As a result of the wide range of information that is now accumulating, it has become possible to obtain an insight into the causes, mec.;hanisms and prevention of birth defects. However, considerable work will be needed before these problems can be resolved. The· contributions in this volume deal primarily with the areas of terato logical evaluation and the use of selected animal models for the study of con genital anomalies. It is not only a documentation of the latest experimental work, but it also indicates new and important areas for future research.

Author : Frank A. Barile
Publisher : CRC Press
Page : 338 pages
File Size : 27,75 MB
Release : 2007-07-23
Category : Medical
ISBN : 1420008323

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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

Author : National Research Council
Publisher : National Academies Press
Page : 402 pages
File Size : 33,34 MB
Release : 1993-02-01
Category : Science
ISBN : 0309048753

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Many of the pesticides applied to food crops in this country are present in foods and may pose risks to human health. Current regulations are intended to protect the health of the general population by controlling pesticide use. This book explores whether the present regulatory approaches adequately protect infants and children, who may differ from adults in susceptibility and in dietary exposures to pesticide residues. The committee focuses on four major areas: Susceptibility: Are children more susceptible or less susceptible than adults to the effects of dietary exposure to pesticides? Exposure: What foods do infants and children eat, and which pesticides and how much of them are present in those foods? Is the current information on consumption and residues adequate to estimate exposure? Toxicity: Are toxicity tests in laboratory animals adequate to predict toxicity in human infants and children? Do the extent and type of toxicity of some chemicals vary by species and by age? Assessing risk: How is dietary exposure to pesticide residues associated with response? How can laboratory data on lifetime exposures of animals be used to derive meaningful estimates of risk to children? Does risk accumulate more rapidly during the early years of life? This book will be of interest to policymakers, administrators of research in the public and private sectors, toxicologists, pediatricians and other health professionals, and the pesticide industry.

Author : OECD
Publisher : OECD Publishing
Page : 10 pages
File Size : 20,63 MB
Release : 1995-07-27
Category :
ISBN : 9264070966

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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 ...