Teratogenicity Testing

Teratogenicity Testing

Author: Luís Félix

Publisher: Humana

Published: 2019-06-27

Total Pages: 614

ISBN-13: 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.


Teratogenicity Testing

Teratogenicity Testing

Author: Paul C. Barrow

Publisher: Humana Press

Published: 2012-11-09

Total Pages: 0

ISBN-13: 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.


Hayes' Principles and Methods of Toxicology

Hayes' Principles and Methods of Toxicology

Author: A. Wallace Hayes

Publisher: CRC Press

Published: 2023-07-03

Total Pages: 2143

ISBN-13: 1000875776

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Hayes’ Principles and Methods of Toxicology has long been established as a reliable and informative reference for the concepts, methodologies, and assessments integral to toxicology. The new edition contains updated and new chapters with the addition of new authors while maintaining the same high standards that have made this book a benchmark resource in the field. Key Features: The comprehensive yet concise coverage of various aspects of fundamental and applied toxicology makes this book a valuable resource for educators, students, and professionals. Questions provided at the end of each chapter allow readers to test their knowledge and understanding of the material covered. All chapters have been updated and over 60 new authors have been added to reflect the dynamic nature of toxicological sciences New topics in this edition include Safety Assessment of Cosmetics and Personal Care Products, The Importance of the Dose/Rate Response, Novel Approaches and Alternative Models, Epigenetic Toxicology, and an Expanded Glossary. The volume is divided into 4 major sections, addressing fundamental principles of toxicology (Section I. "Principles of Toxicology"), major classes of established chemical hazards (Section II. "Agents"), current methods used for the assessment of various endpoints indicative of chemical toxicity (Section III. "Methods"), as well as toxicology of specific target systems and organs (Section IV. "Organ- and System-Specific Toxicology"). This volume will be a valuable tool for the audience that wishes to broaden their understanding of hazards and mechanisms of toxicity and to stay on top of the emerging methods and concepts of the rapidly advancing field of toxicology and risk assessment.


Test No. 421: Reproduction/Developmental Toxicity Screening Test

Test No. 421: Reproduction/Developmental Toxicity Screening Test

Author: OECD

Publisher: OECD Publishing

Published: 1995-07-27

Total Pages: 10

ISBN-13: 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 ...


Toxicology for the Health and Pharmaceutical Sciences

Toxicology for the Health and Pharmaceutical Sciences

Author: Antonio Peña-Fernández

Publisher: CRC Press

Published: 2021-12-21

Total Pages: 531

ISBN-13: 1351398016

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There is an increasing need for knowledge of toxicology to safeguard the use of chemicals in industry and in the public and private sectors. The study of toxicology is becoming increasingly relevant in human health sciences, as future health and clinical professionals will be pivotal in addressing and managing emerging chemical threats and hazards related to modern anthropogenic activities and technological development. Comprising a series of chapters from leading toxicology, pharmacy and public health academics and experts across Europe, the United States and beyond, Toxicology for the Health and Pharmaceutical Sciences provides a concise yet comprehensive volume that can be used as a relevant textbook on toxicology for the clinical, healthcare, educational and professional sectors. Key Features: Includes cutting edge information regarding the very lastest environmental threats to public health Provides a detailed case study based on a real-world scenario that allows the reader to practice human health risk assessment Describes innovative guidance and tools to respond to chemical incidents and attacks, which enables the reader to tailor an effective protection and remediation response This book covers the fundamentals and recent developments in toxicology, to respond to local and global chemical, pharmaceutical and environmental threats. Thus, this volume has chapters specifically designed to support the understanding of the most current toxicology-related subjects for any undergraduate/postgraduate health programs as well as aid the delivery of continuing professional development training on up-to-date topics in toxicology for current practicing health professionals wishing to improve their background knowledge in toxicology. The book is also vital reading and reference for policy makers and others that influence and set regulations that have an impact on the environment and human health.


The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

Author: Joerg Bluemel

Publisher: Academic Press

Published: 2015-03-13

Total Pages: 716

ISBN-13: 012417146X

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The Nonhuman Primate in Drug Development and Safety Assessment is a valuable reference dedicated to compiling the latest research on nonhuman primate models in nonclinical safety assessment, regulatory toxicity testing and translational science. By covering important topics such as study planning and conduct, inter-species genetic drift, pathophysiology, animal welfare legislation, safety assessment of biologics and small molecules, immunotoxicology and much more, this book provides scientific and technical insights to help you safely and successfully use nonhuman primates in pharmaceutical toxicity testing. A comprehensive yet practical guide, this book is intended for new researchers or practicing toxicologists, toxicologic pathologists and pharmaceutical scientists working with nonhuman primates, as well as graduate students preparing for careers in this area. Covers important topics such as species selection, study design, experimental methodologies, animal welfare and the 3Rs (Replace, Refine and Reduce), social housing, regulatory guidelines, comparative physiology, reproductive biology, genetic polymorphisms and more Includes practical examples on techniques and methods to guide your daily practice Offers a companion website with high-quality color illustrations, reference values for safety assessment and additional practical information such as study design considerations, techniques and procedures and dosing and sampling volumes


Environmental Neurotoxicology

Environmental Neurotoxicology

Author: National Research Council

Publisher: National Academies Press

Published: 1992-02-01

Total Pages: 167

ISBN-13: 0309045312

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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.