Drug Device Combination Products

Drug Device Combination Products
Author: Andrew Lewis
Publsiher: Elsevier
Total Pages: 560
Release: 2009-12-15
ISBN 10: 1845697480
ISBN 13: 9781845697488
Language: EN, FR, DE, ES & NL

Drug Device Combination Products Book Review:

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

Biomaterials  Medical Devices  and Combination Products
Author: Shayne Cox Gad,Samantha Gad-McDonald
Publsiher: CRC Press
Total Pages: 606
Release: 2015-12-01
ISBN 10: 1482248387
ISBN 13: 9781482248388
Language: EN, FR, DE, ES & NL

Biomaterials Medical Devices and Combination Products Book Review:

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

Combination Products

Combination Products
Author: Smita Gopalaswamy,Venky Gopalaswamy
Publsiher: CRC Press
Total Pages: 264
Release: 2008-04-22
ISBN 10: 9781420064513
ISBN 13: 1420064517
Language: EN, FR, DE, ES & NL

Combination Products Book Review:

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.

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
Publsiher: Academic Press
Total Pages: 262
Release: 2019-12-12
ISBN 10: 0128131799
ISBN 13: 9780128131794
Language: EN, FR, DE, ES & NL

Assurance of Sterility for Sensitive Combination Products and Materials Book Review:

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

Integrated Safety and Risk Assessment for Medical Devices and Combination Products

Integrated Safety and Risk Assessment for Medical Devices and Combination Products
Author: Shayne C. Gad
Publsiher: Springer Nature
Total Pages: 490
Release: 2020-02-24
ISBN 10: 3030352412
ISBN 13: 9783030352417
Language: EN, FR, DE, ES & NL

Integrated Safety and Risk Assessment for Medical Devices and Combination Products Book Review:

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.

Drug device Combinations for Chronic Diseases

Drug device Combinations for Chronic Diseases
Author: SuPing Lyu,Ronald Siegel
Publsiher: John Wiley & Sons
Total Pages: 280
Release: 2015-12-07
ISBN 10: 1118120000
ISBN 13: 9781118120002
Language: EN, FR, DE, ES & NL

Drug device Combinations for Chronic Diseases Book Review:

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
Author: Eunjoo Pacifici,Susan Bain
Publsiher: Academic Press
Total Pages: 280
Release: 2018-06-13
ISBN 10: 0128111569
ISBN 13: 9780128111567
Language: EN, FR, DE, ES & NL

An Overview of FDA Regulated Products Book Review:

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

Development of Biopharmaceutical Drug Device Products

Development of Biopharmaceutical Drug Device Products
Author: Feroz Jameel,John W. Skoug,Robert R. Nesbitt
Publsiher: Springer Nature
Total Pages: 893
Release: 2020-03-13
ISBN 10: 3030314154
ISBN 13: 9783030314156
Language: EN, FR, DE, ES & NL

Development of Biopharmaceutical Drug Device Products Book Review:

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.

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
Publsiher: Createspace Independent Publishing Platform
Total Pages: 50
Release: 2018-09-22
ISBN 10: 9781727541700
ISBN 13: 1727541707
Language: EN, FR, DE, ES & NL

Postmarketing Safety Reporting for Combination Products Us Food and Drug Administration Regulation Fda 2018 Edition Book Review:

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 of regulated medical products (drugs, devices, and/or biological products, which are referred to as "constituent parts" of a combination product) comprise a combination product and the combination product or its constituent parts have received FDA marketing authorization. The rule is intended to promote and protect the public health by setting forth the requirements for postmarketing safety reporting for these combination products, and is part of FDA's ongoing effort to ensure the consistency and appropriateness of the regulatory requirements for combination products. This book contains: - The complete text of the Postmarketing Safety Reporting for Combination Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section

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
Publsiher: National Academies Press
Total Pages: 442
Release: 2011-04-03
ISBN 10: 0309158060
ISBN 13: 9780309158060
Language: EN, FR, DE, ES & NL

Rare Diseases and Orphan Products Book Review:

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.

International Combination Products

International Combination Products
Author: Gloria Hall
Publsiher: Unknown
Total Pages: 135
Release: 2021-05-21
ISBN 10: 9781947493599
ISBN 13: 1947493590
Language: EN, FR, DE, ES & NL

International Combination Products Book Review:

Medical Regulatory Affairs

Medical Regulatory Affairs
Author: Jack Wong,Raymond K. Y. Tong
Publsiher: CRC Press
Total Pages: 806
Release: 2022-01-27
ISBN 10: 1000440516
ISBN 13: 9781000440515
Language: EN, FR, DE, ES & NL

Medical Regulatory Affairs Book Review:

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.

Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices
Author: Bijan Elahi
Publsiher: Academic Press
Total Pages: 534
Release: 2021-11-11
ISBN 10: 0323918239
ISBN 13: 9780323918237
Language: EN, FR, DE, ES & NL

Safety Risk Management for Medical Devices Book Review:

Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations. Includes new coverage of ISO 14971:2019, ISO/TR 24971 Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation

Clinical Evaluation of Medical Devices

Clinical Evaluation of Medical Devices
Author: Karen M. Becker,John J. Whyte
Publsiher: Springer Science & Business Media
Total Pages: 360
Release: 2007-11-05
ISBN 10: 1597450049
ISBN 13: 9781597450041
Language: EN, FR, DE, ES & NL

Clinical Evaluation of Medical Devices Book Review:

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.

Global Pediatric Development of Drugs Biologics and Medical Devices

Global Pediatric Development of Drugs  Biologics  and Medical Devices
Author: Jocelyn Jennings,Linda McBride
Publsiher: Unknown
Total Pages: 135
Release: 2021-11-26
ISBN 10: 9781947493735
ISBN 13: 1947493736
Language: EN, FR, DE, ES & NL

Global Pediatric Development of Drugs Biologics and Medical Devices Book Review:

Medical Devices Law and Regulation Answer Book

Medical Devices Law and Regulation Answer Book
Author: Susan Onel,Karen M. Becker
Publsiher: Unknown
Total Pages: 1112
Release: 2016-11
ISBN 10: 9781402427749
ISBN 13: 1402427743
Language: EN, FR, DE, ES & NL

Medical Devices Law and Regulation Answer Book Book Review:

This title walks you through the current regulatory requirements and provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations.

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
Publsiher: National Academies Press
Total Pages: 318
Release: 2011-10-25
ISBN 10: 0309212456
ISBN 13: 9780309212458
Language: EN, FR, DE, ES & NL

Medical Devices and the Public s Health Book Review:

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 medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

Public Health Effectiveness of the FDA 510 k Clearance Process

Public Health Effectiveness of the FDA 510 k  Clearance Process
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
Publsiher: National Academies Press
Total Pages: 140
Release: 2010-10-04
ISBN 10: 9780309162906
ISBN 13: 0309162904
Language: EN, FR, DE, ES & NL

Public Health Effectiveness of the FDA 510 k Clearance Process Book Review:

The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

Applied Human Factors in Medical Device Design

Applied Human Factors in Medical Device Design
Author: Mary Beth Privitera
Publsiher: Academic Press
Total Pages: 368
Release: 2019-06-15
ISBN 10: 0128161647
ISBN 13: 9780128161647
Language: EN, FR, DE, ES & NL

Applied Human Factors in Medical Device Design Book Review:

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 design teams. This book is an excellent reference for professionals working in human factors, design, engineering, marketing and regulation. Focuses on meeting agency requirements as it pertains to the application of human factors in the medical device development process in both the US and the European Union (EU) Explains technology development and the application of human factors throughout the development process Covers FDA and MHRA regulations Includes case examples with each method

Smart Materials for Drug Delivery

Smart Materials for Drug Delivery
Author: Carmen Alvarez-Lorenzo,Angel Concheiro
Publsiher: Royal Society of Chemistry
Total Pages: 394
Release: 2013-04-17
ISBN 10: 1849734313
ISBN 13: 9781849734318
Language: EN, FR, DE, ES & NL

Smart Materials for Drug Delivery Book Review:

Smart materials, which can change properties when an external stimulus is applied, can be used for the targeted drug delivery of an active molecule to a specific site in the correct dosage. Different materials such as liposomes, polymeric systems, nanomaterials and hydrogels can respond to different stimuli such as pH, temperature and light and these are all attractive for controlled release applications. With so many papers available on smart and stimuli-responsive materials for drug delivery applications it's hard to know where to start reading about this exciting topic. This two volume set brings together the recent findings in the area and provides a critical analysis of the different materials available and how they can be applied to advanced drug delivery systems. With contributions from leading experts in the field, including a foreword from distinguished scientist Nicholas Peppas, The University of Texas at Austin, USA, the book will provide both an introduction to the key areas for graduate students and new researchers in the stimuli-responsive field as well as serving as a reference for those already working on fundamental materials research or drug delivery applications.