Haschek and Rousseaux's Handbook of Toxicologic Pathology, Volume 2: Safety Assessment and Toxicologic Pathology PDF Download
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Author: Wanda M. Haschek
Publisher: Academic Press
ISBN: 0323910521
Category : Medical
Languages : en
Pages : 694
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Book Description
Haschek and Rousseaux's Handbook of Toxicologic Pathology, recognized by many as the most authoritative single source of information in the field of toxicologic pathology, has been extensively updated to continue its comprehensive and timely coverage. The fourth edition has been expanded to five separate volumes due to an explosion of information in this field requiring new and updated chapters. Completely revised with a number of new chapters, Volume 2: Toxicologic Pathology in Safety Assessment is an essential part of the most authoritative reference on toxicologic pathology principles and techniques for assessing product safety and human risk. Volume 2 describes the integration of product-induced structural and functional changes in tissues and the interpretation of their biological implications. Completely revised with many new chapters, Volume 2 of the Fourth Edition covers product safety assessment from many angles including current and emerging issues in toxicologic pathology for many product classes. Volume 2 of the Handbook of Toxicologic Pathology is a key resource for pathologists, toxicologists, research scientists, and regulators who use toxicologic pathology methods to study and make decisions on product safety. - Previous chapters on such topics as drug discovery and development, toxicity and carcinogenicity testing, report preparation, and risk assessment and communication have undergone extensive revision that includes in-depth discussion of new developments in the field - New chapters consider fundamental attributes for additional product classes including protein therapeutics, nucleic acid pharmaceutical agents, gene therapy and gene editing, stem cell and other cell therapies, vaccines, agricultural and bulk chemicals, and assigning adversity - Chapters dealing with product-specific practices address pathology and regulatory issues - Chapters offer high-quality and up-to-date content in a trusted work written by the collaborative efforts of many leading international subject matter experts - Hundreds of full-color images and diagrams are featured in both the print and electronic versions of this book to illustrate classic examples and highlight difficult concepts
Author: Wanda M. Haschek
Publisher: Academic Press
ISBN: 0323910521
Category : Medical
Languages : en
Pages : 694
Get Book Here
Book Description
Haschek and Rousseaux's Handbook of Toxicologic Pathology, recognized by many as the most authoritative single source of information in the field of toxicologic pathology, has been extensively updated to continue its comprehensive and timely coverage. The fourth edition has been expanded to five separate volumes due to an explosion of information in this field requiring new and updated chapters. Completely revised with a number of new chapters, Volume 2: Toxicologic Pathology in Safety Assessment is an essential part of the most authoritative reference on toxicologic pathology principles and techniques for assessing product safety and human risk. Volume 2 describes the integration of product-induced structural and functional changes in tissues and the interpretation of their biological implications. Completely revised with many new chapters, Volume 2 of the Fourth Edition covers product safety assessment from many angles including current and emerging issues in toxicologic pathology for many product classes. Volume 2 of the Handbook of Toxicologic Pathology is a key resource for pathologists, toxicologists, research scientists, and regulators who use toxicologic pathology methods to study and make decisions on product safety. - Previous chapters on such topics as drug discovery and development, toxicity and carcinogenicity testing, report preparation, and risk assessment and communication have undergone extensive revision that includes in-depth discussion of new developments in the field - New chapters consider fundamental attributes for additional product classes including protein therapeutics, nucleic acid pharmaceutical agents, gene therapy and gene editing, stem cell and other cell therapies, vaccines, agricultural and bulk chemicals, and assigning adversity - Chapters dealing with product-specific practices address pathology and regulatory issues - Chapters offer high-quality and up-to-date content in a trusted work written by the collaborative efforts of many leading international subject matter experts - Hundreds of full-color images and diagrams are featured in both the print and electronic versions of this book to illustrate classic examples and highlight difficult concepts
Author: Bijan Elahi
Publisher: Academic Press
ISBN: 0323918239
Category : Technology & Engineering
Languages : en
Pages : 541
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Book Description
Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations. - Includes new coverage of ISO 14971:2019, ISO/TR 24971 - Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management - Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation
Author: Susan Neadle
Publisher: CRC Press
ISBN: 1000874583
Category : Medical
Languages : en
Pages : 439
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Book Description
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.
Author: A. Wallace Hayes
Publisher: CRC Press
ISBN: 1000875776
Category : Medical
Languages : en
Pages : 2143
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Book Description
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.
Author: Rajiv Kohli
Publisher: Elsevier
ISBN: 0128222174
Category : Technology & Engineering
Languages : en
Pages : 336
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Book Description
Surfactants in Precision Cleaning: Removal of Contaminants at the Micro and Nanoscale is a single source of information on surfactants, emulsions, microemulsions and detergents for removal of surface contaminants at the micro and nanoscale. The topics covered include cleaning mechanisms, effect of surfactants, types of stable dispersions (emulsions, microemulsions, surfactants, detergents, etc.), cleaning technology, and cleaning applications. Users will find this volume an excellent resource on the use of stable dispersions in precision cleaning. - Single source of current information on surfactants, emulsions, microemulsions and detergents for precision cleaning applications - Includes a list of extensive reference sources - Discusses specific selection and properties of surfactants and their use in cleaning - Provides a guide for cleaning applications in different industry sectors
Author: Julian H. Braybrook
Publisher: John Wiley & Sons
ISBN:
Category : Medical
Languages : en
Pages : 256
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Book Description
This book presents both an overview and forward assessment of medical device materials and test methods. Highlighting the complex problem of host responses and related issues which may restrict the accuracy and reliability of existing test methodology, the book provides an unbiased appraisal of the requirements for biocompatibility and the approaches that have been developed to evaluate it.
Author: Björn Wolfgang Schuller
Publisher: Frontiers Media SA
ISBN: 2889746399
Category : Medical
Languages : en
Pages : 197
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Book Description
Author: Vinny R. Sastri
Publisher: William Andrew
ISBN: 0323851274
Category : Technology & Engineering
Languages : en
Pages : 525
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Book Description
Plastics in Medical Devices: Properties, Requirements, and Applications, Third Edition provides a comprehensive overview on the main types of plastics used in medical device applications. The book focuses on the applications and properties that are most important in medical device design, such as chemical resistance, sterilization capability and biocompatibility. The roles of additives, stabilizers and fillers as well as the synthesis and production of polymers are covered and backed up with a wealth of data tables. The book also covers other key aspects in detail, including regulations, compliance, purchasing controls and supplier controls, and process validation. This updated edition has been thoroughly revised with regard to new plastic materials, applications and requirements. This is a valuable resource for engineers, scientists and managers involved in the design and manufacture of medical devices. - Presents detailed coverage of commercially available plastics used in medical device applications, organized by polymer type and supported by data - Includes up-to-date regulatory requirements and practical information on purchasing and supplier controls, process validation and risk management - Supports the development, marketing and commercialization of medical devices and materials for use in medical devices
Author: Dennis Jenke
Publisher: John Wiley & Sons
ISBN: 1119605075
Category : Medical
Languages : en
Pages : 468
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Book Description
EXTRACTABLES AND LEACHABLES Learn to address the safety aspects of packaged drug products and medical devices Pharmaceutical drug products and medical devices are expected to be effective and safe to use. This includes minimizing patient, user or product exposure to impurities leached from these items when the drug product is administered or when the medical device is used. Clearly, patient or user exposure to leachables must not adversely impact their health and safety. Furthermore, these impurities must not adversely affect key quality attributes of the drug product or medical device, including its manufacturability, stability, efficacy, appearance, shelf-life and conformance to standards. Extractables and leachables are derived from the drug product’s packaging, manufacturing systems and/or delivery systems or from the medical device’s materials of construction. It is imperative to understand and quantify the release of extractables from these items, the accumulation of leachables in drug products and the release of leachables from medical devices. Once extractables and leachables have been discovered, identified and quantified, their effect on the key product or device quality attributes, including safety, must be systematically and scientifically established according to recognized, rigorous and relevant regulatory and compendial standards and industry-driven best practices. In Extractables and Leachables, the chemical compatibility (including safe use) of drugs (and their containers, delivery devices and manufacturing systems) and medical devices is examined at length, focusing particularly on how trace-level extractables and leachables affect the quality and safety of a medical product and how to assess the magnitude of the effect. This is accomplished by addressing the two critical activities required to develop, register and commercialize safe, effective and affordable clinical therapies; measuring extractables and leachables (chemical characterization) and assessing their impact (for example, toxicological safety risk assessment). Each of these activities is addressed in-depth, based on the existing and developing international regulations and guidelines, current published literature and the author’s extensive personal experience. Written by a key contributor to standards, guidelines, recommended practices and the scientific literature, the book provides “insider” insights beyond those gained by merely reading the relevant texts. Given that the rapidly evolving extractables and leachables landscape, this book provides the most current and crucial information on new and forthcoming regulations and best practices. Extractables and Leachables readers will also find: A thorough summary of regulatory and compendial guidelines and the steps required to meet them A detailed and in-depth review of essential scientific principles and recommended best practices for the design, implementation, interpretation and reporting of chemical characterization studies A practical resource for optimizing the development, registration, and commercialization of safe and effective medical products A helpful tool to maximize product development and successful regulatory outcomes Extractables and Leachables is the essential reference for pharmaceutical scientists, analytical chemists, regulatory affairs professionals, engineers, and toxicologists in areas such as product research and development, product registration and approval, regulatory affairs, analytical science, quality control, and manufacturing.
Author: Vinny R. Sastri
Publisher: Elsevier
ISBN: 081552028X
Category : Technology & Engineering
Languages : en
Pages : 289
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Book Description
No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.
