Drug Device Combination Products

• Author : Andrew Lewis
• Publisher : Elsevier
• Release : 15 December 2009

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

• Author : SuPing Lyu,Ronald Siegel
• Publisher : John Wiley & Sons
• Release : 07 December 2015

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

• Author : Smita Gopalaswamy,Venky Gopalaswamy
• Publisher : CRC Press
• Release : 22 April 2008

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,

• Author : Shayne Cox Gad,Samantha Gad-McDonald
• Publisher : CRC Press
• Release : 17 November 2015

This book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical safety of the materials used in producing medical devices, and the devices themselves. Starting with material characterization and selection, considerations of concerns arising from packaging and contact with production machinery, and extensive coverage of combination products the book also provides the latest approaches to isolating, quantitating, identifying and assessing the risk arising from chemical entities released from market ready devices.

• Author : Jack Wong,Raymond Tong Kaiyu
• Publisher : CRC Press
• Release : 27 March 2013

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

• Author : Jack Wong,Raymond Tong
• Publisher : CRC Press
• Release : 28 March 2018

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

• Author : Karen M. Becker,John J. Whyte
• Publisher : Springer Science & Business Media
• Release : 05 November 2007

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

• Author : Great Britain. Medicines Control Agency
• Publisher : Unknown
• Release : 03 July 1994

• Author : SuPing Lyu,Ronald Siegel
• Publisher : John Wiley & Sons
• Release : 04 November 2015

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

• Author : Kim Huynh-Ba
• Publisher : Springer Science & Business Media
• Release : 16 November 2008

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.

• Author : Shayne Cox Gad,Samantha Gad-McDonald
• Publisher : CRC Press
• Release : 01 December 2015

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

• Author : Jack Wong,Raymond K. Y. Tong
• Publisher : CRC Press
• Release : 27 January 2022

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

• Author : Amiram Daniel
• Publisher : Quality Press
• Release : 01 January 2008

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

• Author : Shayne C. Gad,Marian G. McCord
• Publisher : CRC Press
• Release : 20 October 2008

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

• Author : Gerald B. Halt,John C. Donch,Amber R. Stiles,Lisa Jenkins VanLuvanee,Brandon R. Theiss,Dana L. Blue
• Publisher : Springer
• Release : 24 January 2019

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