Test No. 475: Mammalian Bone Marrow Chromosome Aberration Test

Test No. 475: Mammalian Bone Marrow Chromosome Aberration Test PDF Author: OECD
Publisher: OECD Publishing
ISBN: 926407130X
Category :
Languages : en
Pages : 8

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Book Description
The mammalian in vivo chromosome aberration test is used for the detection of structural chromosome aberrations induced by test compounds in bone marrow cells of animals, usually rodents (rats, mice and Chinese hamsters). Structural chromosome ...

Test No. 475: Mammalian Bone Marrow Chromosome Aberration Test

Test No. 475: Mammalian Bone Marrow Chromosome Aberration Test PDF Author: OECD
Publisher: OECD Publishing
ISBN: 926407130X
Category :
Languages : en
Pages : 8

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Book Description
The mammalian in vivo chromosome aberration test is used for the detection of structural chromosome aberrations induced by test compounds in bone marrow cells of animals, usually rodents (rats, mice and Chinese hamsters). Structural chromosome ...

OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 475: Mammalian Bone Marrow Chromosomal Aberration Test

OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 475: Mammalian Bone Marrow Chromosomal Aberration Test PDF Author: OECD
Publisher: OECD Publishing
ISBN: 9264264787
Category :
Languages : en
Pages : 18

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Book Description
The mammalian in vivo chromosome aberration test is used for the detection of structural chromosome aberrations induced by test compounds in bone marrow cells of animals, usually rodents (rats, mice and Chinese hamsters).

Test No. 475: Mammalian Bone Marrow Chromosome Aberration Test

Test No. 475: Mammalian Bone Marrow Chromosome Aberration Test PDF Author: Organisation for Economic Co-operation and Development
Publisher:
ISBN:
Category :
Languages : en
Pages :

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Book Description


Drug Safety Evaluation

Drug Safety Evaluation PDF Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 1119755859
Category : Medical
Languages : en
Pages : 996

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Book Description
Drug Safety Evluation Comprehensive and practical guide presenting a roadmap for safety assessment as an integral part of the development of drugs and therapeutics This fourth edition of Drug Safety Evaluation maintains the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, healthcare providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated and shepherding valuable candidates to market. Individual chapters address specific approaches to evaluation hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (e.g., carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching the new problems that have come to face both our society and the new challenges they brought. The many changes in regulatory requirements, pharmaceutical development, technology, and the effects of Covid on our society and science have required both extensive revision to every chapter and the addition of four new chapters. Specific sample topics covered in Drug Safety Evaluation include: The drug development process and the global pharmaceutical marketplace and regulation of human pharmaceutical safety Sources of information for consideration in study and program design and in safety evaluation Electronic records, reporting and submission, screens in safety and hazard assessment, and formulations, routes, and dosage regimens Mechanisms and endpoints of drug toxicity, pilot toxicity testing in drug safety evaluation, and repeat dose toxicity Genotoxicity, QSAR tools for drug safety, toxicogenomics, nonrodent animal studies, and developmental and reproductive toxicity testing An appendix which provides an up to date guide to CROs for conducting studies Drug Safety Evaluation was written specifically for the pharmaceutical and biotechnology industries, including scientists, consultants, and academics, to show a utilitarian yet scientifically valid path to the everyday challenges of safety evaluation and the problem solving that is required in drug discovery and development.

The Role of the Study Director in Nonclinical Studies

The Role of the Study Director in Nonclinical Studies PDF Author: William J. Brock
Publisher: John Wiley & Sons
ISBN: 1118874080
Category : Science
Languages : en
Pages : 568

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Book Description
A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry

Mutagenicity: Assays and Applications

Mutagenicity: Assays and Applications PDF Author: Ashutosh Kumar
Publisher: Academic Press
ISBN: 0128092602
Category : Science
Languages : en
Pages : 352

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Book Description
Mutagenicity: Assays and Applications presents an extensive examination of the detection, assessment and future of mutagenicity, particularly as it concerns human health and the environment. Chapters focused on specific types of mutagens or testing methods for their detection collectively explore the current state of human and environmental mutagenesis, future perspectives and regulatory needs. The test procedures for measuring mutagenicity, their advantages and limitations are described with practical and procedural detail, along with their presentation and data processing aspects. It is an essential reference covering the breadth and depth of the field of mutagenicity studies and regulation. By providing both important introductory material and practical assays and applications, this book is useful to graduate students, academic and industry researchers and regulators at various stages of their careers, leading to improved risk assessment and regulation. Presents an up-to-date and in-depth review of the current state of mutagenesis research Draws upon the combined experience and expertise of an international group of highly respected editors and chapter authors Provides an introduction to the concept of mutagenesis with particular consideration given to novel chemicals and materials

A Practical Guide to Toxicology and Human Health Risk Assessment

A Practical Guide to Toxicology and Human Health Risk Assessment PDF Author: Laura Robinson
Publisher: John Wiley & Sons
ISBN: 1118882075
Category : Science
Languages : en
Pages : 400

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Book Description
Toxicology – the study of the adverse effects of chemicals on living organisms is the cornerstone to all aspects of chemical safety and knowledge of the subject is needed in a wide spectrum of fields from the chemical industry to medicine, emergency services, forensics, and regulatory science. Toxicology involves the study of symptoms, mechanisms, treatments and detection of poisoning ... especially the poisoning of people. The many problems arising from a poor understanding of toxicology and its applications in hazard communication and chemical safety motivated the author’s training courses and webinars, leading to this valuable book. Providing a practical and accessible guide, A Practical Guide to Toxicology and Human Health Risk Assessment enables readers to quickly build up knowledge and understanding of toxicology and its use in hazard identification, which is a fundamental part of chemical risk assessment. The book also covers current toxicological testing strategies and the use of physicochemical test data in hazard identification and exposure assessment. Examples are provided throughout the book to highlight important issues along with a summary of the key points that have been covered in each of the respective chapters. The book concludes with a listing of online resources on toxicology and risk assessment.

Pharmaceutical Toxicology in Practice

Pharmaceutical Toxicology in Practice PDF Author: Alberto Lodola
Publisher: John Wiley & Sons
ISBN: 0470922729
Category : Medical
Languages : en
Pages : 280

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Book Description
This book describes, with references to key source materials, the background to, and conduct of, the principal nonclinical studies that are central to drug development. The chapters provide an understanding of the key components of the preclinical phase of drug development with a hands-on description, with core chapters addressing study conduct, types, and reporting. As such, it is a practical guide through toxicology testing and an up-to-date reference on current issues, new developments, and future directions in toxicology. Opening with a practical description of toxicology and its role in the development of pharmaceuticals, the book proceeds to detail international regulations (including the impact of the new REACH standards for chemical safety), interdisciplinary interactions among scientists in drug development, steps in toxicity testing, and risk management. Further, the book covers the methods of genetic toxicology (assays, genomics, in vivo screening) as a complement to “traditional” toxicology in the risk assessment and risk management of pharmaceuticals.

Nanotechnology Characterization Tools for Environment, Health, and Safety

Nanotechnology Characterization Tools for Environment, Health, and Safety PDF Author: Challa S.S.R. Kumar
Publisher: Springer Nature
ISBN: 3662596008
Category : Technology & Engineering
Languages : en
Pages : 357

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Book Description
Tenth volume of a 40 volume series on nanoscience and nanotechnology, edited by the renowned scientist Challa S.S.R. Kumar. This handbook gives a comprehensive overview about Nanotechnology Characterization Tools for Environment, Health, and Safety. Modern applications and state-of-the-art techniques are covered and make this volume an essential reading for research scientists in academia and industry.

Adverse Effects of Engineered Nanomaterials

Adverse Effects of Engineered Nanomaterials PDF Author: Bengt Fadeel
Publisher: Academic Press
ISBN: 0123869404
Category : Medical
Languages : en
Pages : 367

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Book Description
An essential reference that discusses occupational exposure and the adverse health effects of engineered nanomaterials and highlights current and future biomedical applications of these nanomaterials in relation to nanosafety.