Medical Product Safety Evaluation
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Medical Product Safety Evaluation
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Author : Jie Chen
language : en
Publisher: CRC Press
Release Date : 2018-09-03
Medical Product Safety Evaluation written by Jie Chen and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-09-03 with Mathematics categories.
Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. The book is designed not only for biopharmaceutical professionals, such as statisticians, safety specialists, pharmacovigilance experts, and pharmacoepidemiologists, who can use the book as self-learning materials or in short courses or training programs, but also for graduate students in statistics and biomedical data science for a one-semester course. Each chapter provides supplements and problems as more readings and exercises.
Safety Evaluation In The Development Of Medical Devices And Combination Products Third Edition
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Author : Shayne C. Gad
language : en
Publisher: CRC Press
Release Date : 2008-10-20
Safety Evaluation In The Development Of Medical Devices And Combination Products Third Edition written by Shayne C. Gad and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-10-20 with Medical categories.
Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field. The Third Edition explores these key current trends: global device markets continually advancing technology the increasing harmonization of device safety regulation worldwide Each aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health and Welfare (MHW) perspectives. In addition, the book reflects the role of the continuing growth of technology in the incorporation of science, particularly in the areas of immunotoxicology and toxicokinetics.
Safety Evaluation In The Development Of Medical Devices And Combination Products
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Author : Shayne C. Gad
language : en
Publisher:
Release Date : 2001
Safety Evaluation In The Development Of Medical Devices And Combination Products written by Shayne C. Gad and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001 with MEDICAL categories.
Safety Evaluation Of Medical Devices
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Author : Shayne C. Gad
language : en
Publisher:
Release Date : 1997
Safety Evaluation Of Medical Devices written by Shayne C. Gad and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997 with Medical categories.
"This practical reference examines the implications of biological and chemical interactions of medical devices with human tissue - offering comprehensive coverage on the evaluation of safety in specialty devices, medical and surgical supplies, imaging systems, in vitro diagnostics, and health information systems." "Discussing preapproval and ongoing test requirements necessary for the development of new products, Safety Evaluation of Medical Devices shows how to select individual materials, components, or devices for testing and how to prepare the samples selected...explains cytotoxicity testing for the determination of biocompatibility using mammalian cell cultures...details the evaluation of hemocompatibility and the potential adverse effects of medical devices on the immune system...addresses studies for both short- and long-term implantable devices...delineates possible genotoxic effects of device materials...presents appropriate models for clinical studies of medical devices...describes specialized studies for cardiovascular prostheses, contact lenses and solutions, and tampons as well as the "mouse safety" systemic injection test...and much more."--BOOK JACKET.Title Summary field provided by Blackwell North America, Inc. All Rights Reserved
Safety Evaluation Of Pharmaceuticals And Medical Devices
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Author : Shayne C. Gad
language : en
Publisher: Springer Science & Business Media
Release Date : 2010-10-26
Safety Evaluation Of Pharmaceuticals And Medical Devices written by Shayne C. Gad and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-10-26 with Medical categories.
The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and practice of medicine and the regulation of drugs. The intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man, through development and to market approved (this intent was subsequently extended to cover the closely related medical device biotechnology, and combination product fields) in a concise, abbreviated manner for all the major world market countries.
Integrated Safety And Risk Assessment For Medical Devices And Combination Products
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Author : Shayne C. Gad
language : en
Publisher: Springer Nature
Release Date : 2020-02-24
Integrated Safety And Risk Assessment For Medical Devices And Combination Products written by Shayne C. Gad and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-02-24 with Medical categories.
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.
Safety Evaluation Of Medical Devices
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Author : Shayne C. Gad
language : en
Publisher: CRC Press
Release Date : 2001-12-04
Safety Evaluation Of Medical Devices written by Shayne C. Gad and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001-12-04 with Medical categories.
Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field. The Third Edition explores these key current trends: global device markets continually advancing technology the increasing harmonization of device safety regulation worldwide Each aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health and Welfare (MHW) perspectives. In addition, the book reflects the role of the continuing growth of technology in the incorporation of science, particularly in the areas of immunotoxicology and toxicokinetics.
Drug Safety Evaluation
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Author : Shayne Cox Gad
language : en
Publisher: John Wiley & Sons
Release Date : 2003-09-05
Drug Safety Evaluation written by Shayne Cox Gad and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-09-05 with Medical categories.
Drug Safety Evaluation presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated. Individual chapters address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Author Shayne Gad draws upon over twenty years of experience in toxicology, drug development, and risk assessment, explaining the scientific and philosophical bases for evaluating specific concerns (carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems. Containing information specifically relevant to the pharmaceutical and biotechnology industries, Drug Safety Evaluation covers a wide variety of topics, including: Acute toxicity testing in pharmaceutical safety evaluation Genotoxicity Safety assessment of inhalant drugs Immunotoxicology in pharmaceutical development Large animal studies Evaluation of human tolerance and safety in clinical trials Drug Safety Evaluation provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.
Medical Device Safety
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Author : G.R Higson
language : en
Publisher: CRC Press
Release Date : 2001-10-29
Medical Device Safety written by G.R Higson and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001-10-29 with Medical categories.
Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, en
Statistical Methods For Evaluating Safety In Medical Product Development
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Author : A. Lawrence Gould
language : en
Publisher: John Wiley & Sons
Release Date : 2015-02-23
Statistical Methods For Evaluating Safety In Medical Product Development written by A. Lawrence Gould and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-02-23 with Medical categories.
This book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development. Each chapter provides sufficient detail to the reader to undertake the design and analysis of experiments at various stages of product development, including comprehensive references to the relevant literature. Provides a guide to statistical methods and application in medical product development Assists readers in undertaking design and analysis of experiments at various stages of product development Features case studies throughout the book, as well as, SAS and R code