Drug Device Combination Products

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

Produk Detail:

  • Author : Andrew Lewis
  • Publisher : Elsevier
  • Pages : 560 pages
  • ISBN : 1845697480
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKDrug Device Combination Products

Drug-Device Combination Products

Drug-Device Combination Products
  • Author : Andrew Lewis
  • Publisher : Elsevier
  • Release : 15 December 2009
GET THIS BOOKDrug-Device Combination Products

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

Drug-device Combinations for Chronic Diseases

Drug-device Combinations for Chronic Diseases
  • Author : SuPing Lyu,Ronald Siegel
  • Publisher : John Wiley & Sons
  • Release : 04 November 2015
GET THIS BOOKDrug-device Combinations for Chronic Diseases

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

Biomaterials, Medical Devices, and Combination Products

Biomaterials, Medical Devices, and Combination Products
  • Author : Shayne Cox Gad,Samantha Gad-McDonald
  • Publisher : CRC Press
  • Release : 01 December 2015
GET THIS BOOKBiomaterials, Medical Devices, and Combination Products

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

Assurance of Sterility for Sensitive Combination Products and Materials
  • Author : Byron J. Lambert,Stan Lam,Joyce M. Hansen,Trabue D. Bryans
  • Publisher : Academic Press
  • Release : 12 December 2019
GET THIS BOOKAssurance of Sterility for Sensitive Combination Products and Materials

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

Combination Products

Combination Products
  • Author : Smita Gopalaswamy,Venky Gopalaswamy
  • Publisher : CRC Press
  • Release : 22 April 2008
GET THIS BOOKCombination Products

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,

Postmarketing Safety Reporting for Combination Products (Us Food and Drug Administration Regulation) (Fda) (2018 Edition)

Postmarketing Safety Reporting for Combination Products (Us Food and Drug Administration Regulation) (Fda) (2018 Edition)
  • Author : The Law The Law Library
  • Publisher : Createspace Independent Publishing Platform
  • Release : 22 September 2018
GET THIS BOOKPostmarketing Safety Reporting for Combination Products (Us Food and Drug Administration Regulation) (Fda) (2018 Edition)

Postmarketing Safety Reporting for Combination Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Postmarketing Safety Reporting for Combination Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA or Agency) is issuing regulations to set forth postmarketing safety reporting requirements for combination products. Specifically, this final rule describes the postmarketing safety reporting requirements that apply when two or more different types

Development of Biopharmaceutical Drug-Device Products

Development of Biopharmaceutical Drug-Device Products
  • Author : Feroz Jameel,John W. Skoug,Robert R. Nesbitt
  • Publisher : Springer Nature
  • Release : 13 March 2020
GET THIS BOOKDevelopment of Biopharmaceutical Drug-Device Products

The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and

Rare Diseases and Orphan Products

Rare Diseases and Orphan Products
  • Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
  • Publisher : National Academies Press
  • Release : 03 April 2011
GET THIS BOOKRare Diseases and Orphan Products

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.

An Overview of FDA Regulated Products

An Overview of FDA Regulated Products
  • Author : Eunjoo Pacifici,Susan Bain
  • Publisher : Academic Press
  • Release : 13 June 2018
GET THIS BOOKAn Overview of FDA Regulated Products

Today’s challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key

Cost Analysis Of Terminal Sterilization And Aseptic Processing Methods Of Sensitive Implantable Combination Drug Device Products

Cost Analysis Of Terminal Sterilization And Aseptic Processing Methods Of Sensitive Implantable Combination Drug Device Products
  • Author : Zenabu Bawa-Mamudu
  • Publisher : Unknown Publisher
  • Release : 03 December 2021
GET THIS BOOKCost Analysis Of Terminal Sterilization And Aseptic Processing Methods Of Sensitive Implantable Combination Drug Device Products

Executive Summary Cost Analysis of Terminal Sterilization and Aseptic Processing Methods of Sensitive Implantable Combination Drug Device Products Company X Zenabu Bawa-Mamudu - 4/24/2015 Professional Science Master's in Biotechnology, California State University San Marcos Sterilization is the validated process and method of ensuring that a product after production and packaging is free of microorganisms. Sterility can be achieved through both terminal sterilization which ensures the Sterility Assurance Level of 10-6 level or Probability of Non-Sterile Unit of less than 10-6 and

Applied Human Factors in Medical Device Design

Applied Human Factors in Medical Device Design
  • Author : Mary Beth Privitera
  • Publisher : Academic Press
  • Release : 15 June 2019
GET THIS BOOKApplied Human Factors in Medical Device Design

Applied Human Factors in Medical Device Design describes the contents of a human factors toolbox with in-depth descriptions of both empirical and analytical methodologies. The book begins with an overview of the design control process, integrating human factors as directed by AAMI TIR 59 and experienced practice. It then explains each method, describing why each method is important, its potential impact, when it's ideal to use, and related challenges. Also discussed are other barriers, such as communication breakdowns between users and

Medical Devices and the Public's Health

Medical Devices and the Public's Health
  • Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
  • Publisher : National Academies Press
  • Release : 25 October 2011
GET THIS BOOKMedical Devices and the Public's Health

Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The