QSAR in Safety Evaluation and Risk Assessment

QSAR in Safety Evaluation and Risk Assessment
Author: Huixiao Hong
Publsiher: Elsevier
Total Pages: 566
Release: 2023-08-12
Genre: Science
ISBN: 9780443153402

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QSAR in Safety Evaluation and Risk Assessment provides comprehensive coverage on QSAR methods, tools, data sources, and models focusing on applications in products safety evaluation and chemicals risk assessment. Organized into five parts, the book covers almost all aspects of QSAR modeling and application. Topics in the book include methods of QSAR, from both scientific and regulatory viewpoints; data sources available for facilitating QSAR models development; software tools for QSAR development; and QSAR models developed for assisting safety evaluation and risk assessment. Chapter contributors are authored by a lineup of active scientists in this field. The chapters not only provide professional level technical summarizations but also cover introductory descriptions for all aspects of QSAR for safety evaluation and risk assessment. Provides comprehensive content about the QSAR techniques and models in facilitating the safety evaluation of drugs and consumer products and risk assesment of environmental chemicals Includes some of the most cutting-edge methodologies such as deep learning and machine learning for QSAR Offers detailed procedures of modeling and provides examples of each model's application in real practice

Safety Evaluation

Safety Evaluation
Author: Myron A. Mehlman
Publsiher: Specialist Journals
Total Pages: 278
Release: 1987
Genre: Medical
ISBN: 0911131132

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Drug Safety Evaluation

Drug Safety Evaluation
Author: Shayne Cox Gad
Publsiher: John Wiley & Sons
Total Pages: 918
Release: 2016-11-18
Genre: Medical
ISBN: 9781119097402

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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

Drug Safety Evaluation

Drug Safety Evaluation
Author: Shayne Cox Gad,Dexter W. Sullivan, Jr.
Publsiher: John Wiley & Sons
Total Pages: 996
Release: 2023-01-12
Genre: Medical
ISBN: 9781119755852

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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.

Evaluating Process Safety in the Chemical Industry

Evaluating Process Safety in the Chemical Industry
Author: J. S. Arendt,D K. Lorenzo
Publsiher: John Wiley & Sons
Total Pages: 108
Release: 2010-08-27
Genre: Technology & Engineering
ISBN: 9780470935453

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Quantitative Risk Analysis is a powerful tool used to help manage risk and improve safety. When used appropriately, it provides a rational basis for evaluating process safety and comparing alternative safety improvements. This guide, an update of an earlier American Chemistry Council (ACC) publication utilizing the "hands-on" experience of CPI risk assessment practitioners and safety professionals involved with the CCPS and ACC, explains how managers and users can make better-informed decisions about QRA, and how plant engineers and process designers can better understand, interpret and use the results of a QRA in their plant.

Integrated Safety and Risk Assessment for Medical Devices and Combination Products

Integrated Safety and Risk Assessment for Medical Devices and Combination Products
Author: Shayne C. Gad
Publsiher: Springer Nature
Total Pages: 490
Release: 2020-02-24
Genre: Medical
ISBN: 9783030352417

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While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation. Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex. A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant (yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them. • Identify and verify the most appropriate available data. • As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest. • As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required. • As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required. • Incorporating assessments for special populations such as neonates. • Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments. • Performance and presentation of integrative assessments covering all potential biologic risks. Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.

Computational Toxicology

Computational Toxicology
Author: Sean Ekins
Publsiher: John Wiley & Sons
Total Pages: 450
Release: 2018-02-13
Genre: Science
ISBN: 9781119282563

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Dieses Buch ist ein wichtiges Referenzwerk für Toxikologen in vielen Bereichen und bietet eine umfassende Analyse molekular Modellansätze und Strategien der Risikobewertung von pharmazeutischen und Umweltchemikalien. - Zeigt, was mit rechnergestützter Toxikologie aktuell erreicht werden kann, und wirft einen Blick auf zukünftige Entwicklungen. - Gibt Antworten zu Themen wie Datenquellen, Datenpflege, Behandlung, Modellierung und Interpretation kritischer Endpunkte im Hinblick auf Gefahrenbewertungen im 21. Jahrhundert. - Bündelt herausragende Konzepte und das Wissen führender Autoren in einem einzigartigen Referenzwerk. - Untersucht detailliert QSAR-Modelle, Eigenschaften physiochemischer Arzneistoffe, strukturbasiertes Drug Targeting, die Bewertung chemischer Mischungen und Umweltmodelle. - Behandelt zusätzlich die Sicherheitsbewertung von Verbraucherprodukten und den Bereich chemische Abwehr und bietet Kapitel zu Open-Source-Toxikologie und Big Data.

Evaluating Process Safety in the Chemical Industry

Evaluating Process Safety in the Chemical Industry
Author: J S Arendt
Publsiher: American Institute of Chemical Engineers
Total Pages: 74
Release: 2024
Genre: Electronic Book
ISBN: 0816990743

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Quantitative Risk Analysis is a powerful tool used to help manage risk and improve safety. When used appropriately, it provides a rational basis for evaluating process safety and comparing alternative safety improvements. This guide, an update of an earlier American Chemistry Council (ACC) publication utilizing the "hands-on" experience of CPI risk assessment practitioners and safety professionals involved with the CCPS and ACC, explains how managers and users can make better-informed decisions about QRA, and how plant engineers and process designers can better understand, interpret and use the results of a QRA in their plant.