Drug Device Combination Products Book

Drug Device Combination Products


  • Author : Andrew Lewis
  • Publisher : Elsevier
  • Release Date : 2009-12-15
  • Genre: Medical
  • Pages : 560
  • ISBN 10 : 9781845697488
  • Total Read : 96
  • File Size : 11,6 Mb

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Drug Device Combination Products 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 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

Biomaterials  Medical Devices  and Combination Products Book

Biomaterials Medical Devices and Combination Products


  • Author : Shayne Cox Gad
  • Publisher : CRC Press
  • Release Date : 2015-12-01
  • Genre: Medical
  • Pages : 606
  • ISBN 10 : 9781482248388
  • Total Read : 92
  • File Size : 16,8 Mb

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Biomaterials Medical Devices and Combination Products 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

Assurance of Sterility for Sensitive Combination Products and Materials Book

Assurance of Sterility for Sensitive Combination Products and Materials


  • Author : Byron J. Lambert
  • Publisher : Academic Press
  • Release Date : 2019-12-12
  • Genre: Technology & Engineering
  • Pages : 262
  • ISBN 10 : 9780128131794
  • Total Read : 92
  • File Size : 13,8 Mb

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Assurance of Sterility for Sensitive Combination Products and Materials Summary:

Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals discusses the medical device industry and existing challenges regarding the exciting new world of sensitive combination products (SCPs) and their terminal sterilization. This book reassesses the current assumptions to assure the patient’s best interests are met in the development of increasingly rigorous sterilization methods used to counteract MRSA and other 'super-bugs'. In addition, the book discusses the special challenges faced with implantable medical devices, sterilization requirements and further methods needed for material selection and the design process. This book is unique in taking a holistic, end-to-end approach to sterilization, with a particular focus on materials selection and product design. Introduces sterilization principles at the material selection and design stages Addresses the industry need for new sterilization processes for new medical devices and biomaterials Provides guidance to select the appropriate sterilization technique for newly developed sensitive combination products Examines forward thinking tactics for matching new developments in material compatibility with possible regulatory and QSR strategies

Combination Products Book

Combination Products


  • Author : Smita Gopalaswamy
  • Publisher : CRC Press
  • Release Date : 2008-04-22
  • Genre: Medical
  • Pages : 264
  • ISBN 10 : 1420064517
  • Total Read : 59
  • File Size : 20,5 Mb

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Combination Products 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 first in-depth look at this breakthrough field, Combination Products includes practical guidelines and a detailed step-by-step process for the development of these novel technologies. It addresses the technical, scientific, regulatory, and quality issues that arise when combining drugs, biologics, and medical devices into a single product. It takes a practical, readily applicable approach to discussing the challenges, victories, and pitfalls associated with merging technologies and systems and how to implement these products into the market successfully and in a timely manner. Specifically, this text explores the process from start to finish, establishing a workable design and development plan complete with relevant definitions. It reviews FDA and other regulatory expectations and covers resource requirements, manufacturing pitfalls, post-launch compliance requirements, and agency audits and challenges. Drawing on the experience and expertise of two leaders in their respective fields, Combination Products boasts the credentials of Dr. Smita Gopalaswamy, a 20 year veteran of technical consulting responsibilities in medical device, biologics, and pharmaceutical industries as well as combination products, along with the support of Dr. Venky Gopalaswamy, an expert in business improvement methodologies such as six sigma, lean, and change management, to provide a comprehensive assessment of the field and an efficient and effective approach to the creation and implementation of combination products.

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

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


  • Author : Shayne C. Gad
  • Publisher : CRC Press
  • Release Date : 2008-10-20
  • Genre: Medical
  • Pages : 504
  • ISBN 10 : 9781439809488
  • Total Read : 75
  • File Size : 13,8 Mb

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Safety Evaluation in the Development of Medical Devices and Combination Products Third Edition 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 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 device Combinations for Chronic Diseases Book

Drug device Combinations for Chronic Diseases


  • Author : SuPing Lyu
  • Publisher : John Wiley & Sons
  • Release Date : 2015-12-07
  • Genre: Technology & Engineering
  • Pages : 288
  • ISBN 10 : 9781118120002
  • Total Read : 69
  • File Size : 16,8 Mb

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Drug device Combinations for Chronic Diseases 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, and when they need to work with each other Reviews interactions between human bodies and the drug-device combination products the measurements of these interactions Covers how a drug-device combination product is developed, tested, and regulated Includes case studies of steroid releasing leads, AOA treated tissue heart valves, intrathecal drug delivery pumps, infuse bone grafts, drug eluting stents, and antimicrobial meshes

International Combination Products Book

International Combination Products


  • Author : Gloria Hall
  • Publisher : Unknown
  • Release Date : 2021-05-21
  • Genre: Uncategoriezed
  • Pages : null
  • ISBN 10 : 1947493590
  • Total Read : 80
  • File Size : 12,6 Mb

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International Combination Products Summary:

Rare Diseases and Orphan Products Book

Rare Diseases and Orphan Products


  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release Date : 2011-04-03
  • Genre: Medical
  • Pages : 442
  • ISBN 10 : 9780309158060
  • Total Read : 75
  • File Size : 11,6 Mb

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Rare Diseases and Orphan Products Summary:

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.