Test No. 476: In Vitro Mammalian Cell Gene Mutation Tests using the Hprt and xprt genes

Test No. 476: In Vitro Mammalian Cell Gene Mutation Tests using the Hprt and xprt genes
Author: OECD
Publisher: OECD Publishing
Total Pages: 18
Release: 2015-07-28
Genre:
ISBN: 9264243089

The in vitro mammalian cell gene mutation test can be used to detect gene mutations induced by chemical substances. In this test, the used genetic endpoints measure mutation at hypoxanthine-guanine phosphoribosyl transferase (HPRT), and at a transgene of xanthineguanine phosphoribosyl ...

Test No. 476: In vitro Mammalian Cell Gene Mutation Test

Test No. 476: In vitro Mammalian Cell Gene Mutation Test
Author: OECD
Publisher: OECD Publishing
Total Pages: 10
Release: 1997-07-21
Genre:
ISBN: 9264071326

The in vitro mammalian cell gene mutation test can be used to detect gene mutations induced by chemical substances. In the cell lines the most commonly-used genetic endpoints measure mutation at thymidine kinase (TK) and hypoxanthine-guanine ...

OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 476: In Vitro Mammalian Cell Gene Mutation Tests using the Hprt and xprt genes

OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 476: In Vitro Mammalian Cell Gene Mutation Tests using the Hprt and xprt genes
Author: OECD
Publisher: OECD Publishing
Total Pages: 18
Release: 2016-07-29
Genre:
ISBN: 9264264809

The in vitro mammalian cell gene mutation test can be used to detect gene mutations induced by chemical substances. In this test, the used genetic endpoints measure mutation at hypoxanthine-guanine phosphoribosyl transferase (HPRT), and at a transgene of xanthineguanine phosphoribosyl transferase...

OECD Guidelines for Testing of Chemicals

OECD Guidelines for Testing of Chemicals
Author: Organisation for Economic Co-operation and Development
Publisher: Organisation for Economic Co-operation and Development ; [Montréal : Renouf]
Total Pages:
Release: 1981
Genre: Chemical industry
ISBN: 9789264122215

Genetic Toxicology

Genetic Toxicology
Author: James M. Parry
Publisher: Humana Press
Total Pages: 433
Release: 2011-12-07
Genre: Medical
ISBN: 9781617794209

The evaluation of potential mutagenic activity is a critical step in the assessment of the safety of both new and pre-existing chemical types. In Genetic Toxicology: Principles and Methods, expert contributors help to satisfy the demand for education in this tremendously important area of study. The volume covers three basic areas: the scientific basis of the discipline, the methodologies of the main test assays, and the application of the methods, all aimed primarily at scientists in the safety departments of the industries working with both natural and synthetic chemicals. Written in the highly successful Methods in Molecular BiologyTM 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. Intuitive and cutting-edge, Genetic Toxicology: Principles and Methods provides crucial support to both laboratory workers in providing quality information on the appropriate application of techniques and to study directors in their assay selection and protocol design in this vital field.

OECD Series on Testing and Assessment Overview on genetic toxicology TGs

OECD Series on Testing and Assessment Overview on genetic toxicology TGs
Author: OECD
Publisher: OECD Publishing
Total Pages: 60
Release: 2017-04-13
Genre:
ISBN: 9264274766

Following a general update of the Genetic Toxicology TGs in 2015, the present Document was written to provide succinct and useful information to individuals unfamiliar with genetic toxicology testing, as well as experienced individuals wishing to obtain an overview of the recent changes that ...

Biocompatibility and Performance of Medical Devices

Biocompatibility and Performance of Medical Devices
Author: Jean-Pierre Boutrand
Publisher: Woodhead Publishing
Total Pages: 592
Release: 2019-11-21
Genre: Technology & Engineering
ISBN: 0081026447

Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies. - Presents diverse insights from experts in government, industry and academia - Delivers a comprehensive overview of testing and interpreting medical device performance - Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market

The Environment-Animal-Human Web: A “One Health” View of Toxicological Risk Analysis

The Environment-Animal-Human Web: A “One Health” View of Toxicological Risk Analysis
Author: Chiara Frazzoli
Publisher: Frontiers Media SA
Total Pages: 154
Release: 2019-04-09
Genre:
ISBN: 2889457915

One Health (OH) is the conceptual and operational framework that links environment, food-producing organisms and human health. OH is a developing field, that deals with the multifaceted web of feed-backs and interactions among its components. In order to avoid “drowning into complexity”, priority issues should be identified, either for research and for risk analysis. To date OH approaches have frequently pivoted on infectious agents shared among animals and humans and the related problems, such as antibiotic resistance. Nevertheless, the OH scenarios include, and should increasingly include, environment-and-health problems. Food and environment do interact. Environment influences the living organisms that produce human food and, in the meanwhile, food production outputs influence the environmental quality; as for foods of animal origin, feed materials and practices are driving components of the environment-food interactions. In this book, we aimed at highlighting the importance of environment, chemical exposures and toxicological issues in the field of OH, as well as the need for multidisciplinary integration in order to support OH approaches into diseases prevention and health promotion.

Drug Safety Evaluation

Drug Safety Evaluation
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
Total Pages: 1753
Release: 2016-12-01
Genre: Medical
ISBN: 111909741X

This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition