The Future of Predictive Safety Evaluation

A. N. Worden

ISBN 10: 9401079366 / ISBN 13: 9789401079365

Published by Springer, Springer Netherlands Dez 2011, 2011

About this Item

This item is printed on demand - Print on Demand Titel. Neuware -Reproduction and fetal development in humans and experimental animals may be adversely affected by a wide range of drugs and environmental agents. They may be toxic in the parental generation leading to impaired germ cell formation, loss of reproductive poten tial and infertility following chronic exposure. Deviant fetal development occurs as a consequence of cellular damage at sensi tive stages in development. Changes seen range from intrauterine mortality and structural malformation to growth retardation with physiological and behavioural defects. Concepts on the mechanism of action of teratogens are discussed with reference to some better-known agents. Presently, regulatory authorities prefer whole animal studies in predictive safety evaluation of substances to which a pregnant woman may be exposed. Tests are conducted over one or more generations and are designed to study the influence of test com pounds upon general reproductive performance, fertility, fetal development and perinatal and postnatal behaviour. Experiments are designed to permit compounds to be tested under conditions resembling expected human exposure. Small rodents and rabbits are preferred species on account of their convenience as laboratory animals and the available knowledge regarding their reproductive behaviour, fetal development and known sensitivity to human teratogens.Springer-Verlag KG, Sachsenplatz 4-6, 1201 Wien 324 pp. Englisch.

Seller Inventory # 9789401079365

Bibliographic Details

• Title: The Future of Predictive Safety Evaluation
• Publisher: Springer, Springer Netherlands Dez 2011
• Publication Date: 2011
• Language: English
• ISBN 10: 9401079366
• ISBN 13: 9789401079365
• Binding: Taschenbuch
• Condition: Neu
• Dimensions: 235W x 155H x 18D millimeters 235 millimeters width by 155 millimeters height by 18 millimeters depth
• Weight: 493 grams

About this title

Synopsis

Reproduction and fetal development in humans and experimental animals may be adversely affected by a wide range of drugs and environmental agents. They may be toxic in the parental generation leading to impaired germ cell formation, loss of reproductive poten­ tial and infertility following chronic exposure. Deviant fetal development occurs as a consequence of cellular damage at sensi­ tive stages in development. Changes seen range from intrauterine mortality and structural malformation to growth retardation with physiological and behavioural defects. Concepts on the mechanism of action of teratogens are discussed with reference to some better-known agents. Presently, regulatory authorities prefer whole animal studies in predictive safety evaluation of substances to which a pregnant woman may be exposed. Tests are conducted over one or more generations and are designed to study the influence of test com­ pounds upon general reproductive performance, fertility, fetal development and perinatal and postnatal behaviour. Experiments are designed to permit compounds to be tested under conditions resembling expected human exposure. Small rodents and rabbits are preferred species on account of their convenience as laboratory animals and the available knowledge regarding their reproductive behaviour, fetal development and known sensitivity to human teratogens.