Skip to main content

Drug Device Combination Products

In Order to Read Online or Download Drug Device Combination Products Full eBooks in PDF, EPUB, Tuebl and Mobi you need to create a Free account. Get any books you like and read everywhere you want. Fast Download Speed ~ Commercial & Ad Free. We cannot guarantee that every book is in the library!

Drug Device Combination Products

Drug Device Combination Products Book
Author : Andrew Lewis
Publisher : Elsevier
Release : 2009-12-15
ISBN : 1845697480
Language : En, Es, Fr & De

GET BOOK

Book Description :

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 Combinations for Chronic Diseases

Drug device Combinations for Chronic Diseases Book
Author : SuPing Lyu,Ronald Siegel
Publisher : John Wiley & Sons
Release : 2015-12-07
ISBN : 1118120000
Language : En, Es, Fr & De

GET BOOK

Book Description :

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

Combination Products

Combination Products Book
Author : Smita Gopalaswamy,Venky Gopalaswamy
Publisher : CRC Press
Release : 2008-04-22
ISBN : 9781420064513
Language : En, Es, Fr & De

GET BOOK

Book Description :

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.

Implementation of EC Medical Devices Directive

Implementation of EC Medical Devices Directive Book
Author : Great Britain. Medicines Control Agency
Publisher : Unknown
Release : 1994
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

Download Implementation of EC Medical Devices Directive book written by Great Britain. Medicines Control Agency, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Clinical Evaluation of Medical Devices

Clinical Evaluation of Medical Devices Book
Author : Karen M. Becker,John J. Whyte
Publisher : Springer Science & Business Media
Release : 2007-11-05
ISBN : 1597450049
Language : En, Es, Fr & De

GET BOOK

Book Description :

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 regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997, the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved, reflecting some of the changes and needs within the medical device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers, with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies, including examples of combination pr- ucts, three-phase development models (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel study designs.

Development of Biopharmaceutical Drug Device Products

Development of Biopharmaceutical Drug Device Products Book
Author : Feroz Jameel,John W. Skoug,Robert R. Nesbitt
Publisher : Springer Nature
Release : 2020-03-13
ISBN : 3030314154
Language : En, Es, Fr & De

GET BOOK

Book Description :

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 process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide “one stop shopping” for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field.

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 Book
Author : Zenabu Bawa-Mamudu
Publisher : Unknown
Release : 2015
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

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 aseptic processing which ensures the equivalent of 10-3. The Sterility Assurance Levels (SAL) is the statistical probability of a microorganism surviving during the process (Mosely, 2008). Sterilization science continues to pursue the most effective means of sustaining this regulatory requirement. This is driven in large part by the evolution of sensitive combination products that cannot tolerate the harsh conditions of terminal sterilization. Division 1 and Division 2 are divisions of Company X, a biotechnology company that specializes in the manufacturing of implantable combination drug and medical devices for use in ophthalmic, cardiac, and vascular care and intervention. Trends in sterilization sciences directly impact Company X across all divisions. Observing these trends and influences enables the company to proactively adapt to changes that impact both existing as well as future products. The project investigated the cost of development, validation, and implementation of different sterilization models. The aim of the project was to also provide metrics to be applied as a measurement tool. The metric can be used in making knowledge based decisions on the most cost effective and time efficient sterilization modality for next generation of combination drug device products that meets Regulatory requirements for Sterility Assurance Level. The project closely examined the different terminal sterilization modalities adopted by Division 1 and Division 2, which includes Ethylene Oxide (EO) and Radiation (E-Beam) sterilization, as well as Aseptic processing methods for sensitive implantable combination drug and device. An analysis was performed using Company X combination drug and device products as models to represent the different sterilization modalities. A series of interviews and tours were completed to gather data, analyze, and compare the sterilization validation and production cost. The following sterilization cost evaluation metrics was developed, Production Sterilization Distribution Time, Sterilization Process Time, Sterilization Cost per Unit, Annual Sterilization Capacity, and Sterilization Method Revalidation Cost and an analysis was performed using these metric and measurements. The analysis showed significant differences between the three sterilization modalities. The overall results indicated that the E-beam Radiation sterilization method provided the lowest Production Sterilization Distribution Time, Sterilization Process Time, Sterilization Cost per Unit, Sterilization Method Revalidation Cost, and Labor Cost. E-beam Radiation also provided the highest Annual Sterilization Capacity when compared to Ethylene Oxide and Aseptic Processing methods. The approach and metrics developed in this project have application in investigation of cost effectiveness of other sterilization methods. Further research can use the developed metrics to evaluate sterilization methods for a range of Sterility Assurance Levels (SAL) that are deemed safe and on site sterilization models such as Hydrogen Peroxide (H2O2) and Nitrogen Dioxide (NO2), that offer similar if not the same advantages as on site E-Beam.

Biomaterials Medical Devices and Combination Products

Biomaterials  Medical Devices  and Combination Products Book
Author : Shayne Cox Gad,Samantha Gad-McDonald
Publisher : CRC Press
Release : 2015-12-01
ISBN : 1482248387
Language : En, Es, Fr & De

GET BOOK

Book Description :

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

Introduction to Drug Device Combination Products Regulation

Introduction to Drug Device Combination Products Regulation Book
Author : Michor Salma
Publisher : Unknown
Release : 2019
ISBN : 9783903024953
Language : En, Es, Fr & De

GET BOOK

Book Description :

Download Introduction to Drug Device Combination Products Regulation book written by Michor Salma, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices Book
Author : Amiram Daniel
Publisher : Quality Press
Release : 2008-01-01
ISBN : 0873897404
Language : En, Es, Fr & De

GET BOOK

Book Description :

How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs.

Handbook of Medical Device Regulatory Affairs in Asia

Handbook of Medical Device Regulatory Affairs in Asia Book
Author : Jack Wong,Raymond Tong Kaiyu
Publisher : CRC Press
Release : 2013-03-27
ISBN : 9814411213
Language : En, Es, Fr & De

GET BOOK

Book Description :

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 registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.

Handbook of Medical Device Regulatory Affairs in Asia

Handbook of Medical Device Regulatory Affairs in Asia Book
Author : Jack Wong,Raymond Tong
Publisher : CRC Press
Release : 2018-03-28
ISBN : 0429996764
Language : En, Es, Fr & De

GET BOOK

Book Description :

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 registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. 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. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.

FDA and Intellectual Property Strategies for Medical Device Technologies

FDA and Intellectual Property Strategies for Medical Device Technologies Book
Author : Gerald B. Halt,John C. Donch,Amber R. Stiles,Lisa Jenkins VanLuvanee,Brandon R. Theiss,Dana L. Blue
Publisher : Springer
Release : 2019-01-24
ISBN : 3030044629
Language : En, Es, Fr & De

GET BOOK

Book Description :

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 introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations, and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection. This book also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by medical device designers, developers and innovators.

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 Book
Author : Shayne C. Gad,Marian G. McCord
Publisher : CRC Press
Release : 2008-10-20
ISBN : 9781420071641
Language : En, Es, Fr & De

GET BOOK

Book Description :

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.

Medical Regulatory Affairs

Medical Regulatory Affairs Book
Author : Jack Wong,Raymond K. Y. Tong
Publisher : CRC Press
Release : 2022-01-27
ISBN : 1000440532
Language : En, Es, Fr & De

GET BOOK

Book Description :

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 (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.

Drug device Combinations for Chronic Diseases

Drug device Combinations for Chronic Diseases Book
Author : SuPing Lyu,Ronald Siegel
Publisher : John Wiley & Sons
Release : 2015-11-04
ISBN : 1119003008
Language : En, Es, Fr & De

GET BOOK

Book Description :

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

An Overview of FDA Regulated Products

An Overview of FDA Regulated Products Book
Author : Eunjoo Pacifici,Susan Bain
Publisher : Academic Press
Release : 2018-06-13
ISBN : 0128111569
Language : En, Es, Fr & De

GET BOOK

Book Description :

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 information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations

FDA Regulatory Affairs

FDA Regulatory Affairs Book
Author : David Mantus,Douglas J. Pisano
Publisher : CRC Press
Release : 2014-02-28
ISBN : 1841849197
Language : En, Es, Fr & De

GET BOOK

Book Description :

FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.

Handbook of Stability Testing in Pharmaceutical Development

Handbook of Stability Testing in Pharmaceutical Development Book
Author : Kim Huynh-Ba
Publisher : Springer Science & Business Media
Release : 2008-11-16
ISBN : 0387856277
Language : En, Es, Fr & De

GET BOOK

Book Description :

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.

Clarification of When Products Made Or Derived from Tobacco Are Regulated as Drugs Devices Or Combination Products Amendments to Regulations Us Food and Drug Administration Regulation Fda 2018 Edition

Clarification of When Products Made Or Derived from Tobacco Are Regulated as Drugs  Devices  Or Combination Products   Amendments to Regulations  Us Food and Drug Administration Regulation   Fda   2018 Edition  Book
Author : The Law The Law Library
Publisher : Createspace Independent Publishing Platform
Release : 2018-09-11
ISBN : 9781727283419
Language : En, Es, Fr & De

GET BOOK

Book Description :

Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products - Amendments to Regulations (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products - Amendments to Regulations (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA) is issuing this final rule to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is intended to provide direction to regulated industry and to help avoid consumer confusion. This book contains: - The complete text of the Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products - Amendments to Regulations (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section