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

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Drug Device Combination Products 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

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

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Biomaterials Medical Devices and Combination Products Excerpt :

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 Book

Combination Products


  • Author : Smita Gopalaswamy
  • Publisher : CRC Press
  • Release Date : 2008-04-22
  • Genre: Medical
  • Pages : 264
  • ISBN 10 : 1420064517

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Combination Products Excerpt :

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 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

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Assurance of Sterility for Sensitive Combination Products and Materials Excerpt :

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 Book

Integrated Safety and Risk Assessment for Medical Devices and Combination Products


  • Author : Shayne C. Gad
  • Publisher : Springer Nature
  • Release Date : 2020-02-24
  • Genre: Medical
  • Pages : 490
  • ISBN 10 : 9783030352417

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Integrated Safety and Risk Assessment for Medical Devices and Combination Products Excerpt :

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 cov

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

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

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.

Development of Biopharmaceutical Drug Device Products Book

Development of Biopharmaceutical Drug Device Products


  • Author : Feroz Jameel
  • Publisher : Springer Nature
  • Release Date : 2020-03-13
  • Genre: Medical
  • Pages : 893
  • ISBN 10 : 9783030314156

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Development of Biopharmaceutical Drug Device Products Excerpt :

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 analytica

An Overview of FDA Regulated Products Book

An Overview of FDA Regulated Products


  • Author : Eunjoo Pacifici
  • Publisher : Academic Press
  • Release Date : 2018-06-13
  • Genre: Medical
  • Pages : 280
  • ISBN 10 : 9780128111567

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An Overview of FDA Regulated Products Excerpt :

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

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

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 Date : 2018-09-22
  • Genre: Uncategoriezed
  • Pages : 50
  • ISBN 10 : 1727541707

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

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 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

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Rare Diseases and Orphan Products Excerpt :

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.

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: Medical
  • Pages : 280
  • ISBN 10 : 9781118120002

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Drug device Combinations for Chronic Diseases Excerpt :

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

Medical Device Development Book

Medical Device Development


  • Author : Jonathan S. Kahan
  • Publisher : Barnett Educational Services / Chi
  • Release Date : 2009
  • Genre: Law
  • Pages : 546
  • ISBN 10 : 1882615921

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Medical Device Development Excerpt :

Medical Regulatory Affairs Book

Medical Regulatory Affairs


  • Author : Jack Wong
  • Publisher : CRC Press
  • Release Date : 2022-01-27
  • Genre: Medical
  • Pages : 806
  • ISBN 10 : 9781000440515

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Medical Regulatory Affairs Excerpt :

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 Book

Safety Risk Management for Medical Devices


  • Author : Bijan Elahi
  • Publisher : Academic Press
  • Release Date : 2021-11-11
  • Genre: Technology & Engineering
  • Pages : 534
  • ISBN 10 : 9780323918237

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Safety Risk Management for Medical Devices Excerpt :

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