Read Books Online and Download eBooks, EPub, PDF, Mobi, Kindle, Text Full Free.
Download Fundamentals Of Law And Regulation An In Depth Look At Therapeutic Products full books in PDF, epub, and Kindle. Read online Fundamentals Of Law And Regulation An In Depth Look At Therapeutic Products ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!
Author : Robert P. Brady
Publisher : Fdli
ISBN 13 :
Total Pages : 652 pages
Book Rating : 4.F/5 ( download)
Download or read book Fundamentals of Law and Regulation: An in-depth look at therapeutic products written by Robert P. Brady and published by Fdli. This book was released on 1997 with total page 652 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : David G. Adams
Publisher :
ISBN 13 : 9781885259608
Total Pages : 84 pages
Book Rating : 4.2/5 (596 download)
Download or read book Fundamentals of Law and Regulation written by David G. Adams and published by . This book was released on 1999 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Richard R. Abood
Publisher : Jones & Bartlett Learning
ISBN 13 : 1284290697
Total Pages : 850 pages
Book Rating : 4.2/5 (842 download)
Download or read book Pharmacy Practice and the Law written by Richard R. Abood and published by Jones & Bartlett Learning. This book was released on 2023-11-02 with total page 850 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmacy Practice and the Law, Tenth Edition not only helps students prepare for their upcoming board exam, but also urges them to understand and critically analyze the law that governs both the profession and the products they distribute. With the most up-to-date federal, legal, regulatory, and policy developments, as well as new developments to various medical and pharmaceutical programs, the Tenth Edition provides a comprehensive overview with an accessible, student-friendly writing style.
Author : United States. Congress. House. Committee on Government Reform. Subcommittee on Criminal Justice, Drug Policy, and Human Resources
Publisher :
ISBN 13 :
Total Pages : 642 pages
Book Rating : 4.0/5 ( download)
Download or read book RU-486 written by United States. Congress. House. Committee on Government Reform. Subcommittee on Criminal Justice, Drug Policy, and Human Resources and published by . This book was released on 2007 with total page 642 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ezekiel J. Emanuel
Publisher : OUP USA
ISBN 13 : 0199768633
Total Pages : 848 pages
Book Rating : 4.1/5 (997 download)
Download or read book The Oxford Textbook of Clinical Research Ethics written by Ezekiel J. Emanuel and published by OUP USA. This book was released on 2011-02 with total page 848 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students.
Author : Richard Abood
Publisher : Jones & Bartlett Learning
ISBN 13 : 0763781290
Total Pages : 474 pages
Book Rating : 4.7/5 (637 download)
Download or read book Pharmacy Practice and The Law written by Richard Abood and published by Jones & Bartlett Learning. This book was released on 2011 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Sixth Edition of this best-selling text includes updates to account for new legal, regulatory and policy developments. Pharmacy Practice and the Law, Sixth Edition provides background, history and discussion of the law so as to enable the student to not only learn the facts, but to help them understand, apply and critically evaluate the information. The issues covered in this text are discussed in non-legal, easy to understand language. Challenging open-ended discussion questions and edited cases are included in every chapter to facilitate discussion and critical thinking. Citations to all laws, court cases, regulations and other documents are provided. An online instructor’s manual is available. Pharmacy Practice and the Law, Sixth Edition, is a useful resource both for teaching the facts of pharmacy law and for stimulating critical thinking issues in pharmacy law.
Author : I. Glenn Cohen
Publisher : Cambridge University Press
ISBN 13 : 1108983030
Total Pages : 295 pages
Book Rating : 4.1/5 (89 download)
Download or read book The Future of Medical Device Regulation written by I. Glenn Cohen and published by Cambridge University Press. This book was released on 2022-04-07 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulators have been more permissive for medical devices compared to their drug and biologic counterparts. While innovative products can thereby reach consumers more quickly, this approach raises serious public health and safety concerns. Additionally, the nature of medical devices is rapidly changing, as software has become as important as hardware. Regulation must keep pace with the current developments and controversies of this technology. This volume provides a multidisciplinary evaluation of the ethical, legal, and regulatory concerns surrounding medical devices in the US and EU. For medical providers, policymakers, and other stakeholders, the book offers a framework for the opportunities and challenges on the horizon for medical device regulation. Readers will gain a nuanced overview of the latest developments in patient privacy and safety, innovation, and new regulatory laws. This book is also available as Open Access on Cambridge Core.
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 111909741X
Total Pages : 1753 pages
Book Rating : 4.1/5 (19 download)
Download or read book Drug Safety Evaluation written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2016-12-01 with total page 1753 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309212421
Total Pages : 318 pages
Book Rating : 4.3/5 (92 download)
Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-11-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author : United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher :
ISBN 13 :
Total Pages : 32 pages
Book Rating : 4.:/5 (31 download)
Download or read book Dietary Supplements written by United States. Federal Trade Commission. Bureau of Consumer Protection and published by . This book was released on 1998 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Shayne Cox Gad
Publisher : CRC Press
ISBN 13 : 1482248387
Total Pages : 606 pages
Book Rating : 4.4/5 (822 download)
Download or read book Biomaterials, Medical Devices, and Combination Products written by Shayne Cox Gad and published by CRC Press. This book was released on 2015-12-01 with total page 606 pages. Available in PDF, EPUB and Kindle. Book 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
Author : Kimberly A. Burns
Publisher : Jones & Bartlett Learning
ISBN 13 : 1284154971
Total Pages : 421 pages
Book Rating : 4.2/5 (841 download)
Download or read book Pharmacy Practice and the Law written by Kimberly A. Burns and published by Jones & Bartlett Learning. This book was released on 2019-02-15 with total page 421 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Ninth Edition of the best-selling text, Pharmacy Practice and the Law goes beyond preparation for the board exam, helping students understand and critically analyze the law that governs both the profession and the products they distribute. The Ninth Edition continues to include the most up to date federal, legal, regulatory, policy developments, as well as new developments to various medical/pharmaceutical programs. Challenging, open-ended discussion questions and edited cases are included in every chapter to facilitate discussion and critical thinking. Critical issues are discussed in non-legal, easy-to-understand language. Pharmacy Practice and the Law, Ninth Edition is the most comprehensive and engaging resource for teaching the facts of federal pharmacy law and for encouraging critical thinking and analysis on the issues.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309133947
Total Pages : 346 pages
Book Rating : 4.3/5 (91 download)
Download or read book The Future of Drug Safety written by Institute of Medicine and published by National Academies Press. This book was released on 2007-02-27 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.
Author : Armin Von Bogdandy
Publisher : Martinus Nijhoff Publishers
ISBN 13 : 9004142851
Total Pages : 479 pages
Book Rating : 4.0/5 (41 download)
Download or read book Max Planck Yearbook of United Nations Law, Volume 8 (2004) written by Armin Von Bogdandy and published by Martinus Nijhoff Publishers. This book was released on 2004-01-01 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: Volume eight comprises topics like the United Nations system of the use of force; the U.S. bilateral non-surrender agreements in relation to the ICC; developing countries, non-traditional intellectual property rights and the WIPO; and fact-finding by UN human rights complaints bodies.
Author : Daniel Carpenter
Publisher : Princeton University Press
ISBN 13 : 1400835119
Total Pages : 856 pages
Book Rating : 4.4/5 (8 download)
Download or read book Reputation and Power written by Daniel Carpenter and published by Princeton University Press. This book was released on 2014-04-24 with total page 856 pages. Available in PDF, EPUB and Kindle. Book excerpt: How the FDA became the world's most powerful regulatory agency The U.S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield its extraordinary power? Reputation and Power traces the history of FDA regulation of pharmaceuticals, revealing how the agency's organizational reputation has been the primary source of its power, yet also one of its ultimate constraints. Daniel Carpenter describes how the FDA cultivated a reputation for competence and vigilance throughout the last century, and how this organizational image has enabled the agency to regulate an industry as powerful as American pharmaceuticals while resisting efforts to curb its own authority. Carpenter explains how the FDA's reputation and power have played out among committees in Congress, and with drug companies, advocacy groups, the media, research hospitals and universities, and governments in Europe and India. He shows how FDA regulatory power has influenced the way that business, medicine, and science are conducted in the United States and worldwide. Along the way, Carpenter offers new insights into the therapeutic revolution of the 1940s and 1950s; the 1980s AIDS crisis; the advent of oral contraceptives and cancer chemotherapy; the rise of antiregulatory conservatism; and the FDA's waning influence in drug regulation today. Reputation and Power demonstrates how reputation shapes the power and behavior of government agencies, and sheds new light on how that power is used and contested. Some images inside the book are unavailable due to digital copyright restrictions.
Author : Russ B. Altman
Publisher : Cambridge University Press
ISBN 13 : 1107377471
Total Pages : 283 pages
Book Rating : 4.1/5 (73 download)
Download or read book Principles of Pharmacogenetics and Pharmacogenomics written by Russ B. Altman and published by Cambridge University Press. This book was released on 2012-01-23 with total page 283 pages. Available in PDF, EPUB and Kindle. Book excerpt: The study of pharmacogenetics and pharmacogenomics focuses on how our genes and complex gene systems influence our response to drugs. Recent progress in clinical therapeutics has led to the discovery of new biomarkers that make it technically easier to identify groups of patients which are more or less likely to respond to individual therapies. The aim is to improve personalised medicine - not simply to prescribe the right medicine, but to deliver the right drug at the right dose at the right time. This textbook brings together leading experts to discuss the latest information on how human genetics impacts drug response phenotypes. It presents not only the basic principles of pharmacogenetics, but also clinically valuable examples that cover a broad range of specialties and therapeutic areas. This textbook is an invaluable introduction to pharmacogenetics and pharmacogenomics for health care professionals, medical students, pharmacy students, graduate students and researchers in the biosciences.
Author : Shayne C. Gad
Publisher : CRC Press
ISBN 13 : 9781439876084
Total Pages : 576 pages
Book Rating : 4.8/5 (76 download)
Download or read book Safety Evaluation of Medical Devices written by Shayne C. Gad and published by CRC Press. This book was released on 2001-12-04 with total page 576 pages. Available in PDF, EPUB and Kindle. Book 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.
