Development and Control of Medicines and Medical Devices - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Development and Control of Medicines and Medical Devices write by Robin J. Harman. This book was released on 2004. Development and Control of Medicines and Medical Devices available in PDF, EPUB and Kindle. This new title describes the tests and processes undertaken to bring new medicines and medical devices to the market, and the work of the government agencies which ensure products of the highest standard. The text covers the controls to prove quality, safety, and efficacy prior to marketing, and postmarketing pharmacovigilance requirements. The different European registration processes for both medicines and medical devices are explained. Important ethical issues in their development are also reviewed. The role of the UK and pan-European regulatory authorities for medicines and medicinal devices (the MHRA and the EMEA), and of the National Institute for Clinical Excellence (NICE), are explained. A review of the ICH process, and of the activities of the US FDA and the World Health Organization (WHO) in drug and device regulation illustrate how other countries control these products. Providing a comprehensive single-volume review, Development and Control of Medicines and Medicinal Devices is an invaluable reference for all students undertaking healthcare studies and for all pharmacists. It is also an essential source for all working in the pharmaceutical and medical devices industries and in government agencies involved in the control of medicines and medical devices.
Modern Methods of Clinical Investigation
Modern Methods of Clinical Investigation - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Modern Methods of Clinical Investigation write by Institute of Medicine. This book was released on 1990-02-01. Modern Methods of Clinical Investigation available in PDF, EPUB and Kindle. The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Combination Products
Combination Products - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Combination Products write by Smita Gopalaswamy. This book was released on 2008-04-22. Combination Products available in PDF, EPUB and Kindle. 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
Rare Diseases and Orphan Products
Rare Diseases and Orphan Products - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Rare Diseases and Orphan Products write by Institute of Medicine. This book was released on 2011-04-03. Rare Diseases and Orphan Products available in PDF, EPUB and Kindle. 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.
The Role of Human Factors in Home Health Care
The Role of Human Factors in Home Health Care - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook The Role of Human Factors in Home Health Care write by National Research Council. This book was released on 2010-11-14. The Role of Human Factors in Home Health Care available in PDF, EPUB and Kindle. The rapid growth of home health care has raised many unsolved issues and will have consequences that are far too broad for any one group to analyze in their entirety. Yet a major influence on the safety, quality, and effectiveness of home health care will be the set of issues encompassed by the field of human factors research-the discipline of applying what is known about human capabilities and limitations to the design of products, processes, systems, and work environments. To address these challenges, the National Research Council began a multidisciplinary study to examine a diverse range of behavioral and human factors issues resulting from the increasing migration of medical devices, technologies, and care practices into the home. Its goal is to lay the groundwork for a thorough integration of human factors research with the design and implementation of home health care devices, technologies, and practices. On October 1 and 2, 2009, a group of human factors and other experts met to consider a diverse range of behavioral and human factors issues associated with the increasing migration of medical devices, technologies, and care practices into the home. This book is a summary of that workshop, representing the culmination of the first phase of the study.
