OECD Series on Testing and Assessment Fundamental And Guiding Principles For (Q)SAR Analysis Of Chemical Carcinogens with Mechanistic Considerations

OECD Series on Testing and Assessment Fundamental And Guiding Principles For (Q)SAR Analysis Of Chemical Carcinogens with Mechanistic Considerations PDF

Author: OECD

Publisher: OECD Publishing

Published: 2017-04-13

Total Pages: 85

ISBN-13: 9264274790

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In this document the importance of mechanistic consideration in quantitative structure-activity relationship ((Q)SAR) analysis, the critical role of mechanistic consideration in improving various (Q)SAR approaches and possible integrative approaches of combining chemoinformatics and ...

OECD Series on Testing and Assessment Guidance Document on the Reporting of Defined Approaches to be Used Within Integrated Approaches to Testing and Assessment

OECD Series on Testing and Assessment Guidance Document on the Reporting of Defined Approaches to be Used Within Integrated Approaches to Testing and Assessment PDF

Author: OECD

Publisher: OECD Publishing

Published: 2017-04-13

Total Pages: 23

ISBN-13: 9264274820

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With a view to assisting the evaluation of integrated approaches to testing and assessment (IATA) in regulatory decision-making within OECD Member Countries, this guidance document provides a set of principles for reporting defined approaches to testing and assessment that can be used as one of ...

Advances in QSAR Modeling

Advances in QSAR Modeling PDF

Author: Kunal Roy

Publisher: Springer

Published: 2017-05-22

Total Pages: 555

ISBN-13: 3319568507

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The book covers theoretical background and methodology as well as all current applications of Quantitative Structure-Activity Relationships (QSAR). Written by an international group of recognized researchers, this edited volume discusses applications of QSAR in multiple disciplines such as chemistry, pharmacy, environmental and agricultural sciences addressing data gaps and modern regulatory requirements. Additionally, the applications of QSAR in food science and nanoscience have been included – two areas which have only recently been able to exploit this versatile tool. This timely addition to the series is aimed at graduate students, academics and industrial scientists interested in the latest advances and applications of QSAR.

Mixture Toxicity

Mixture Toxicity PDF

Author: Cornelis A. M. van Gestel

Publisher: CRC Press

Published: 2016-04-19

Total Pages: 312

ISBN-13: 1439830096

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In the last decade and a half, great progress has been made in the development of concepts and models for mixture toxicity, both in human and environmental toxicology. However, due to their different protection goals, developments have often progressed in parallel but with little integration. Arguably the first book to clearly link ecotoxicology an

Alternatives to Animal Testing

Alternatives to Animal Testing PDF

Author: Hajime Kojima

Publisher: Springer

Published: 2018-12-27

Total Pages: 130

ISBN-13: 9811324476

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This open access book presents recent advances in the pure sciences that are of significance in the quest for alternatives to the use of animals in research and describes a variety of practical applications of the three key guiding principles for the more ethical use of animals in experiments – replacement, reduction, and refinement, collectively known as the 3Rs. Important examples from across the world of implementation of the 3Rs in the testing of cosmetics, chemicals, pesticides, and biologics, including vaccines, are described, with additional information on relevant regulations. The coverage also encompasses emerging approaches to alternative tests and the 3Rs. The book is based on the most informative contributions delivered at the Asian Congress 2016 on Alternatives and Animal Use in the Life Sciences. It will be of value for those working in R&D, for graduate students, and for educators in various fields, including the pharmaceutical and cosmetic sciences, pharmacology, toxicology, and animal welfare. The free, open access distribution of Alternatives to Animal Testing is enabled by the Creative Commons Attribution license in International version 4: CC BY 4.0.

In Silico Toxicology

In Silico Toxicology PDF

Author: Mark T. D. Cronin

Publisher: Royal Society of Chemistry

Published: 2010

Total Pages: 689

ISBN-13: 1849730040

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This book defines the use of computational approaches to predict the environmental toxicity and human health effects of organic chemicals.

Mutagenic Impurities

Mutagenic Impurities PDF

Author: Andrew Teasdale

Publisher: John Wiley & Sons

Published: 2022-02-15

Total Pages: 548

ISBN-13: 1119551218

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Learn to implement effective control measures for mutagenic impurities in pharmaceutical development In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective. The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on the purge tool for risk assessment. The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination. Readers will also benefit from the inclusion of: A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities A discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents Perfect for chemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control will also earn a place in the libraries of toxicologists and clinical safety scientists seeking a one-stop reference on the subject of mutagenic impurity identification and control.

Genotoxicity and Carcinogenicity Testing of Pharmaceuticals

Genotoxicity and Carcinogenicity Testing of Pharmaceuticals PDF

Author: Michael J. Graziano

Publisher: Springer

Published: 2015-11-02

Total Pages: 214

ISBN-13: 3319220845

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This book provides an overview of the nonclinical testing strategies that are used to asses and de-risk the genotoxicity and carcinogenicity properties of human pharmaceuticals. It includes a review of relevant ICH guidelines, numerous case studies where follow-up studies were conducted to further investigate positive findings, and practical considerations for the use of alternative and emerging tests. With contributions from recognized experts in the pharmaceutical industry and health authorities, this volume presents a balanced view on the interpretation and application of genotoxicity and carcinogenicity regulatory guidances. Genotoxicity and Carcinogenicity Testing of Pharmaceuticals is a valuable resource for scientists, regulators, and consultants that are engaged in the conduct, reporting, and review of nonclinical studies. This book will also help academicians better understand and appreciate the complexity of the regulations and breadth of toxicology research that are necessary to support the development and marketing of new drugs.

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