File Name: teratogenicity testing methods and protocols .zip
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Kimberly C. Brannen, Robert E. Chapin, Abigail C. Jacobs, Maia L. In the pharmaceutical industry, preclinical developmental and reproductive toxicity studies are conducted in laboratory animals in order to predict and prevent adverse effects of drugs on human reproductive health and development. However, these studies require a relatively large number of animals and are usually conducted late in the drug development process.
It seems that you're in Germany. We have a dedicated site for Germany. 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. 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.
Not a MyNAP member yet? Register for a free account to start saving and receiving special member only perks. Animals have been used as sentinels for early detection of potential risk to humans or as models to study the causes, pathogenesis, progression, and treatment of diseases. The latter use gave rise to the field of investigative toxicology, wherein animals are used as surrogates to predict possible adverse health effects to humans arising from chemical exposures. That approach is challenged by some people for scientific, ethical, and philosophic reasons, but the use of animal models to assess hazards and risks to humans continues to be the standard for protecting human health. Over the last several decades, scientists have developed standardized protocols for testing potentially hazardous chemicals to ensure sound scientific methods and generation of high-quality data that are critical for assessing human hazards and risks.
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Protocol DOI: The rat is the rodent species of choice for the regulatory safety testing of xenobiotics, such as medicinal products, food additives, and other chemicals. Many decades of experience and extensive data have accumulated for both general and. Many decades of experience and extensive data have accumulated for both general and developmental toxicology investigations in this species.
Stem cells in the body have a unique ability to renew themselves and give rise to more specialized cell types having functional commitments. Under specified growth conditions, these cell types remain unspecialized but can be triggered to become specific cell type of the body such as heart, nerve, or skin cells.
Read terms. Wharton, MD. This document reflects emerging clinical and scientific advances as of the date issued and is subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed.
Teratogenesis refers to the production of defects in the fetus. A teratogenic agent is responsible for producing such a defect.
Request PDF | Teratogenicity Testing: Methods and Protocols | This detailed book provides a compilation of laboratory techniques and tests to assess the risks.