Biocompatibility and Performance of Medical Devices

Biocompatibility and Performance of Medical Devices PDF Author: Jean-Pierre Boutrand
Publisher: Woodhead Publishing
ISBN: 0081026447
Category : Technology & Engineering
Languages : en
Pages : 592

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Book Description
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

Biocompatibility and Performance of Medical Devices

Biocompatibility and Performance of Medical Devices PDF Author: Jean-Pierre Boutrand
Publisher: Woodhead Publishing
ISBN: 0081026447
Category : Technology & Engineering
Languages : en
Pages : 592

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Book Description
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

Haschek and Rousseaux's Handbook of Toxicologic Pathology, Volume 1: Principles and Practice of Toxicologic Pathology

Haschek and Rousseaux's Handbook of Toxicologic Pathology, Volume 1: Principles and Practice of Toxicologic Pathology PDF Author: Wanda M. Haschek
Publisher: Academic Press
ISBN: 0128218290
Category : Medical
Languages : en
Pages : 1154

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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 four 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 1, "Principles and the Practice of Toxicologic Pathology," covers the practice of toxicologic pathology in three parts: Principles of Toxicologic Pathology, Methods in Toxicologic Pathology, and the Practice of Toxicologic Pathology. Other volumes in this work round out the depth and breadth of coverage.Volume 2 encompasses "Toxicologic Pathology in Safety Assessment" and "Environmental Toxicologic Pathology". These two sections cover the application of toxicologic pathology in developing specific product classes, principles of data interpretation for safety assessment, and toxicologic pathology of major classes of environmental toxicants. Volumes 3 and 4 provide deep and broad treatment of "Target Organ Toxicity", emphasizing the comparative and correlative aspects of normal biology and toxicant-induced dysfunction, principal methods for toxicologic pathology evaluation, and major mechanisms of toxicity. These volumes comprise the most authoritative reference on toxicologic pathology for pathologists, toxicologists, research scientists, and regulators studying and making decisions on drugs, biologics, medical devices, and other chemicals, including agrochemicals and environmental contaminants. Each volume is being published separately. - Provides new chapters on digital pathology, juvenile pathology, in vitro/in vivo correlation, big data technologies and in-depth discussion of timely topics in the area of toxicologic pathology - Offers high-quality and trusted content in a multi-contributed work written by leading international authorities in all areas of toxicologic pathology - Features hundreds of full-color images in both the print and electronic versions of the book to highlight difficult concepts with clear illustrations

Toxicologic Pathology

Toxicologic Pathology PDF Author: Pritam S. Sahota
Publisher: CRC Press
ISBN: 0429997450
Category : Medical
Languages : en
Pages : 1776

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Book Description
Following the success of the first edition, this book is designed to provide practical and timely information for toxicologic pathologists working in pharmaceutical drug discovery and development. The majority of the book (Organ Systems) will provide detailed descriptions of histopathological lesions observed in drug development. In addition, it will provide information to assist the pathologist in making determinations of the origin of lesions as well as its relevance to human risk. Toxicologic Pathology: Nonclinical Safety Assessment, Second Edition includes 2 new concept chapters. The first of the new chapters address approaches for the evaluation of unique therapeutic modalities such as cell therapies, gene therapies, and gene expression knockdown therapies. While these still represent new developing therapeutic approaches, there has been significant experience with the therapeutic modalities in the last 5 years. The second new chapter addresses the nonclinical safety assessment of medical devices, a topic of increasing importance that was not addressed in a unique chapter in the first edition. The other concept chapters have been updated and cover important topics including the overview of drug development; principles of nonclinical safety assessment; an introduction to toxicologic pathology; techniques used in toxicologic pathology, clinical pathology, toxicokinetics, and drug development toxicogenomics; and spontaneous lesions. The 13 organ system chapters provide the specifics related to pathologic characteristics, differential diagnosis, and interpretation of toxic responses in each organ system. These chapters are specifically important for the bench pathologist but also for the toxicologist who interacts with pathologists and function as study toxicologists and project team representatives in the drug development arena.

Diagnostic Pathology: Neuropathology E-Book

Diagnostic Pathology: Neuropathology E-Book PDF Author: B.K. Kleinschmidt-DeMasters
Publisher: Elsevier Health Sciences
ISBN: 0323713319
Category : Medical
Languages : en
Pages : 1035

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Book Description
Covering all aspects of neuropathology, this updated volume in the Diagnostic Pathology series is an excellent point-of-care resource for pathologists at all levels of experience and training—both as a quick reference and as an efficient review to improve knowledge and skills. The third edition is an easy-to-use, one-stop reference for the most recent clinical, pathological, histological, and molecular knowledge in the field. It offers complete information on lesions of the brain, sellar region, and peripheral nerves, as well as benign cysts and selected infectious, inflammatory, reactive, vascular, and cortical dysplastic lesions, enabling you to arrive at the correct diagnosis and prepare actionable, useful reports. - Incorporates new WHO Classification of Tumors of the Central Nervous System, 5th Edition - Offers information on neoplasms of the brain, sellar region, and peripheral nerves, as well as benign cysts and selected infectious, inflammatory, reactive, and vascular lesions, aiding you in arriving at the correct diagnosis - Emphasizes surgical pathology but also provides significant content on nonneoplastic diseases that present with focal lesions, especially those that are potentially misinterpreted as neoplasms - Contains a detailed molecular diagnostics chapter with a section on methylation profiling, which has become indispensable as a method of tumor classification - Features new and updated chapters detailing several types of tumors that have been reclassified due to recent molecular driver information, cIMPACT-NOW recommendations, and the WHO Classification, 5th Edition

Diagnostic Pathology: Hepatobiliary and Pancreas E-Book

Diagnostic Pathology: Hepatobiliary and Pancreas E-Book PDF Author: Laura W. Lamps
Publisher: Elsevier Health Sciences
ISBN: 0323776213
Category : Medical
Languages : en
Pages : 567

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Book Description
This expert volume in the Diagnostic Pathology series is an excellent point-of-care resource for practitioners at all levels of experience and training. Covering all areas of neoplastic and nonneoplastic diseases of the digestive tract and accessory organs such as the pancreas and liver, it incorporates the most recent clinical, pathological, and molecular knowledge in the field to provide a comprehensive overview of all key issues relevant to today's practice. Richly illustrated and easy to use, Diagnostic Pathology: Hepatobiliary and Pancreas is a one-stop reference for accurate, complete pathology reports, ideal as a day-to-day reference or as a reliable training resource. - Analyzes hundreds of diagnoses, each of which include critical diagnostic information such as definitions, epidemiology, clinical presentation, macro- and microscopic features, differential diagnoses, and pathologic interpretation pearls. - Features thorough updates throughout, including novel immunohistochemical markers and other ancillary techniques (such as BAP1, INSM1, Rb, albumin in situ hybridization) that play an increasingly critical role in improving diagnoses - Addresses recent advances in molecular pathology—new diagnostic, immunohistochemical, molecular, and genetic techniques used for diagnosis, as well as new details about the genesis and activity of tumors in the liver, pancreas, and biliary systems - Includes details from the 2019 WHO Classification of Tumors of the Digestive System regarding important changes to diagnostic techniques, identification of new variants of cancers, and immunohistochemical markers and ancillary techniques that improve diagnosis and treatment options - Reflects recent WHO updates and updates from the AJCC's 8th Edition Cancer Staging Manual such as new terminology, new grading of neuroendocrine tumors and neuroendocrine carcinomas, and characteristic molecular alterations in hepatocellular adenoma, cholangiocarcinoma, and other tumors - Uses a templated page layout, bulleted text, and a generous number of high-quality images to help practicing and in-training pathologists reach a confident diagnosis

Wheater's Basic Pathology: A Text, Atlas and Review of Histopathology E-Book

Wheater's Basic Pathology: A Text, Atlas and Review of Histopathology E-Book PDF Author: Barbara Young
Publisher: Elsevier Health Sciences
ISBN: 1437728758
Category : Medical
Languages : en
Pages : 349

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Book Description
Wheater's Basic Pathology: A Text, Atlas and Review of Histopathology, 5th Edition, by Barbara Young, BSc, Med Sci(Hons), PhD, MB, BChir, MRCP, FRCPA, Geraldine O'Dowd, BSc(Hons), MBChB(Hons), FRCPath and William Stewart, BSc (Hons), MBChB, PhD, DipFMS, FRCPath is a pathology resource that offers a comprehensive introduction to the subject first by covering fundamental pathological processes and then addressing the common diseases encountered in systems pathology. Hundreds of high-quality images illustrate the essential features of pathology and make it easy to make definitive comparisons to your own lab samples, while concise captions enable you to quickly and easily understand key points. Wheater's Basic Pathology is an excellent companion resource for users of Wheater's Functional Histology, Wheater's Review of Histology, and Basic Pathology, or Robbins and Cotran Pathology Flash Cards. This title includes additional digital media when purchased in print format. For this digital book edition, media content is not included. Offers discussions of basic pathological processes as well as coverage of common diseases encountered in systems pathology for a complete review. Includes comprehensive updates, with relevant molecular pathology issues explained in the context of the clinical presentation, the treatment implications, and the underlying pathological processes Presents nearly 650 images of the highest quality that vividly and clearly illustrate the essential features of pathology and enable you to make definitive comparisons to your own lab views. Features concise text that distills basic and complex information into a coherent explanation to help you understand key points quickly and easily. Provides keys to the lettering in images at the bottom of each page, saving you time in reviewing figures. Serves as a companion text to Wheater’s Functional Histology, 5th Edition, offering a comparison of normal histology with the pathological changes in disease. Features a short review section at the end of each chapter covering the key point of the chapter in brief form for the perfect pairing of reference and review. Includes online access to Student Consult where you'll find the complete text and illustrations from the book, fully searchable • and additional USMLE-style questions for self assessment Provides additional colored text boxes with clinical-pathological correlations that explain the relevance of the pathological processes underlying common diseases and their complications. FOR FACULTY Features online access to Evolve Resources including a high-resolution image bank with all the illustrations, figures and tables from the book, and a test bank.

Autopsy Pathology: A Manual and Atlas

Autopsy Pathology: A Manual and Atlas PDF Author: Andrew J Connolly
Publisher: Elsevier Health Sciences
ISBN: 0323287808
Category : Medical
Languages : en
Pages : 403

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Book Description
A mainstay for pathology residents, Autopsy Pathology is designed with a uniquely combined manual and atlas format that presents today's most complete coverage of performing, interpreting, and reporting post-mortem examinations. This lasting and useful medical reference book offers a practical, step-by-step approach to discussing not only the basics of the specialty, but the performance of specialized autopsy procedures as well. Material is divided into two sections for ease of use: a manual covering specific autopsy procedures, biosafety, generation of autopsy reports, preparation of death certificates, and other essential subjects; and an atlas, organized by organ system, which captures the appearance of the complete spectrum of autopsy findings. Offers expanded coverage of microscopic anatomy. Includes a chapter on performing special dissection procedures that may not be covered during a typical residency. Examines important techniques, such as autopsy photography and radiology, microscopic examination, supplemental laboratory studies, and other investigative approaches. Addresses the latest legal, social, and ethical issues relating to autopsies, as well as quality improvement and assurance. Presents more than 600 full-color photographs depicting common gross and microscopic autopsy findings for every part of the body. Correlates pathologic findings with their clinical causes to enhance diagnostic accuracy. Improved images in the Atlas section provide greater visual understanding. Additional online features include dissection videos demonstrating autopsy techniques; downloadable, commonly used forms for autopsy reports; and calculators for weights and measures. Expert Consult eBook version included with purchase. This enhanced eBook experience offers access to all of the text, figures, images, videos, forms, calculators, and references from the book on a variety of devices.

Cardiovascular Pathology

Cardiovascular Pathology PDF Author: L. Maximilian Buja
Publisher: Academic Press
ISBN: 0128004592
Category : Science
Languages : en
Pages : 833

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Book Description
Cardiovascular Pathology, Fourth Edition, provides users with a comprehensive overview that encompasses its examination, cardiac structure, both normal and physiologically altered, and a multitude of abnormalities. This updated edition offers current views on interventions, both medical and surgical, and the pathology related to them. Congenital heart disease and its pathobiology are covered in some depth, as are vasculitis and neoplasias. Each section has been revised to reflect new discoveries in clinical and molecular pathology, with new chapters updated and written with a practical approach, especially with regards to the discussion of pathophysiology. New chapters reflect recent technological advances with cardiac devices, transplants, genetics, and immunology. Each chapter is highly illustrated and covers contemporary aspects of the disease processes, including a section on the role of molecular diagnostics and cytogenetics as specifically related to cardiovascular pathology. Customers buy the Print + Electronic product together! Serves as a contemporary, all-inclusive guide to cardiovascular pathology for clinicians and researchers, as well as clinical residents and fellows of pathology, cardiology, cardiac surgery, and internal medicine Offers new organization of each chapter to enable uniformity for learning and reference: Definition, Epidemiology, Clinical Presentation, Pathogenesis/Genetics, Light and Electron Microscopy/Immunohistochemistry, Differential Diagnosis, Treatment and Potential Complications Features six new chapters and expanded coverage of the normal heart and blood vessels, cardiovascular devices, congenital heart disease, tropical and infectious cardiac disease, and forensic pathology of the cardiovascular system Contains 400+ full color illustrations and an online image collection facilitate research, study, and lecture slide creation

Diagnostic Pathology: Head and Neck E-Book

Diagnostic Pathology: Head and Neck E-Book PDF Author: Lester D. R. Thompson
Publisher: Elsevier Health Sciences
ISBN: 0323428576
Category : Medical
Languages : en
Pages : 1193

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Book Description
Part of the highly regarded Diagnostic Pathology series, this updated volume is a visually stunning, easy-to-use reference covering all aspects of head and neck pathology. Outstanding images—including gross and microscopic pathology, a wide range of stains, and detailed medical illustrations—make this an invaluable diagnostic aid for every practicing pathologist, resident, or fellow. This second edition incorporates the most recent clinical, pathological, histological, and molecular knowledge in the field to provide a comprehensive overview of all key issues relevant to today’s practice. Highly templated text allows for quicky, easy reference. As always, Amirsys titles are image-rich. Thoroughly updated content throughout including new coverage of oropharyngeal carcinoma; HPV-associated, mammary analogue secretory carcinoma; EWSR1 driven tumors; molecular pathways as targets for salivary duct carcinoma; and much more High-quality, carefully annotated color images (50% new!) provide clinically and diagnostically important information on more than 315 new and evolving entities of the head and neck and endocrine organs State-of-the-art coverage of tumors, tumor development, and tumor genetics as well as normal histology, genetic testing, and new immunohistochemistry studies Fully integrated, searchable, and linked content between differential diagnostic categories is perfectly suited for residents, while updated genetic testing algorithms, new images, and outstanding graphics make this text ideal for both residents and practitioners Supporting studies are placed into clinical context, with tables and molecular flow charts that assist with management decisions and prognostic outcome predictions Time-saving reference features include bulleted text, a variety of test data tables, key facts in each chapter, annotated images, and an extensive index Expert Consult eBook version included with purchase. This enhanced eBook experience allows you to search all of the text, figures, images, and references from the book on a variety of devices.

Modern Methods of Clinical Investigation

Modern Methods of Clinical Investigation PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309042860
Category : Medical
Languages : en
Pages : 241

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Book Description
The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.