Drug Device Combination Products

Written By Andrew Lewis
Drug Device Combination Products
  • Publsiher : Elsevier
  • Release : 15 December 2009
  • ISBN : 1845697480
  • Pages : 560 pages
  • Rating : 4/5 from 21 reviews
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Read or download book entitled Drug Device Combination Products written by Andrew Lewis which was release on 15 December 2009, this book published by Elsevier. Available in PDF, EPUB and Kindle Format. Book excerpt: Drug delivery systems represent a vast area of research and development within biomaterials and medicine and the demand for sophisticated drug delivery devices continues to drive novel product development. Advanced drug delivery devices can offer significant advantages over conventional drugs and devices alone, such as increased efficiency, improved performance and convenience. The purpose of this book is to illustrate how effective drug delivery can be achieved by means other than tablets. The book will provide a thorough analysis of the fundamentals, applications and new technologies of drug-device combination products for use throughout the human body. Part one provides readers with an introduction and background to the field. Chapters in Part two discuss areas of application such as catheter based products, drug eluting stents and beads and anti-biotic loaded cements. Part three covers the development of drug device combination products with chapters on such topics as pre-clinical testing, sterilisation, patent issues and regulation of drug device combination products. With its distinguished editor and team of international contributors, Drug-device combination products: delivery technologies and applications is an invaluable reference for product development specialists, materials scientists and engineers in the biomedical industry and academia as well as those concerned with drug delivery. Illustrates how effective drug delivery can be achieved by means other than tablets providing readers with a comprehensive introduction and background to the field Provides a thorough analysis of the fundamentals, applications and new technologies of drug device combination products Discusses areas of application such as catheter based products and reviews the development of drug device combination products including pre-clinical testing and sterilisation

Drug Device Combination Products

Drug Device Combination Products
  • Author : Andrew Lewis
  • Publisher : Elsevier
  • Release Date : 2009-12-15
  • Total pages : 560
  • ISBN : 1845697480
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Summary : Drug delivery systems represent a vast area of research and development within biomaterials and medicine and the demand for sophisticated drug delivery devices continues to drive novel product development. Advanced drug delivery devices can offer significant advantages over conventional drugs and devices alone, such as increased efficiency, improved performance and ...

Drug device Combinations for Chronic Diseases

Drug device Combinations for Chronic Diseases
  • Author : SuPing Lyu,Ronald Siegel
  • Publisher : John Wiley & Sons
  • Release Date : 2015-11-04
  • Total pages : 280
  • ISBN : 1845697480
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Summary : This book covers two areas, the first detailing the concepts and technologies of drug-device combination products. The second area includes case studies of important products that either significantly shape our technologies and thinking, or contribute to current healthcare practice. The book: Discusses where drugs and devices work, where they fail, ...

Combination Products

Combination Products
  • Author : Smita Gopalaswamy,Venky Gopalaswamy
  • Publisher : CRC Press
  • Release Date : 2008-04-22
  • Total pages : 264
  • ISBN : 1845697480
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Summary : The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by this nascent but fast-growing area. Providing the ...

Clinical Evaluation of Medical Devices

Clinical Evaluation of Medical Devices
  • Author : Karen M. Becker,John J. Whyte
  • Publisher : Springer Science & Business Media
  • Release Date : 2007-11-05
  • Total pages : 360
  • ISBN : 1845697480
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Summary : The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and ...

Handbook of Medical Device Regulatory Affairs in Asia

Handbook of Medical Device Regulatory Affairs in Asia
  • Author : Jack Wong,Raymond Tong
  • Publisher : CRC Press
  • Release Date : 2018-03-28
  • Total pages : 620
  • ISBN : 1845697480
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Summary : Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful ...

Biomaterials Medical Devices and Combination Products

Biomaterials  Medical Devices  and Combination Products
  • Author : Shayne Cox Gad,Samantha Gad-McDonald
  • Publisher : CRC Press
  • Release Date : 2015-11-17
  • Total pages : 560
  • ISBN : 1845697480
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Summary : This book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical safety of the materials used in producing medical devices, and the devices themselves. Starting with material characterization and selection, considerations of concerns arising from packaging and contact with production machinery, and ...

Implementation of EC Medical Devices Directive

Implementation of EC Medical Devices Directive
  • Author : Great Britain. Medicines Control Agency
  • Publisher : Unknown
  • Release Date : 1994
  • Total pages : 5
  • ISBN : 1845697480
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Summary : Download or read online Implementation of EC Medical Devices Directive written by Great Britain. Medicines Control Agency, published by which was released on 1994. Get Implementation of EC Medical Devices Directive Books now! Available in PDF, ePub and Kindle....

Handbook of Medical Device Regulatory Affairs in Asia

Handbook of Medical Device Regulatory Affairs in Asia
  • Author : Jack Wong,Raymond Tong Kaiyu
  • Publisher : CRC Press
  • Release Date : 2013-03-27
  • Total pages : 616
  • ISBN : 1845697480
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Summary : Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful ...

FDA and Intellectual Property Strategies for Medical Device Technologies

FDA and Intellectual Property Strategies for Medical Device Technologies
  • Author : Gerald B. Halt,John C. Donch,Amber R. Stiles,Lisa Jenkins VanLuvanee,Brandon R. Theiss,Dana L. Blue
  • Publisher : Springer
  • Release Date : 2019-01-24
  • Total pages : 333
  • ISBN : 1845697480
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Summary : This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are ...

Medical Regulatory Affairs

Medical Regulatory Affairs
  • Author : Jack Wong,Raymond K. Y. Tong
  • Publisher : CRC Press
  • Release Date : 2022-01-27
  • Total pages : 806
  • ISBN : 1845697480
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Summary : This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (...

Handbook of Stability Testing in Pharmaceutical Development

Handbook of Stability Testing in Pharmaceutical Development
  • Author : Kim Huynh-Ba
  • Publisher : Springer Science & Business Media
  • Release Date : 2008-11-16
  • Total pages : 389
  • ISBN : 1845697480
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Summary : This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices....

Biomaterials Medical Devices and Combination Products

Biomaterials  Medical Devices  and Combination Products
  • Author : Shayne Cox Gad,Samantha Gad-McDonald
  • Publisher : CRC Press
  • Release Date : 2015-12-01
  • Total pages : 606
  • ISBN : 1845697480
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Summary : Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for-or concerned with-developing and ensuring patient safety in the use and manufacture of medical devices.The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical...

Safety Evaluation in the Development of Medical Devices and Combination Products Third Edition

Safety Evaluation in the Development of Medical Devices and Combination Products  Third Edition
  • Author : Shayne C. Gad,Marian G. McCord
  • Publisher : CRC Press
  • Release Date : 2008-10-20
  • Total pages : 504
  • ISBN : 1845697480
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Summary : 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 ...

Safety Evaluation in the Development of Medical Devices and Combination Products Third Edition

Safety Evaluation in the Development of Medical Devices and Combination Products  Third Edition
  • Author : Shayne C. Gad,Marian G. McCord
  • Publisher : CRC Press
  • Release Date : 2008-10-20
  • Total pages : 504
  • ISBN : 1845697480
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Summary : 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 ...

The Challenges of Conducting Medical Device Studies

The Challenges of Conducting Medical Device Studies
  • Author : Keith Summerhayes
  • Publisher : Inst of Clinical Research
  • Release Date : 2005-01
  • Total pages : 82
  • ISBN : 1845697480
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Summary : Describing all the regulations, guidelines and directives that affect medical device studies....