From Discovery To Commercialization

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Social Aspects of Drug Discovery, Development and Commercialization

Author : Odilia Osakwe
Publisher : Academic Press
ISBN 13 : 0128024976
Total Pages : 326 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Social Aspects of Drug Discovery, Development and Commercialization by : Odilia Osakwe

Download or read book Social Aspects of Drug Discovery, Development and Commercialization written by Odilia Osakwe and published by Academic Press. This book was released on 2016-02-18 with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt: Social Aspects of Drug Discovery, Development and Commercialization provides an insightful analysis of the drug discovery and development landscape as it relates to society. This book examines the scientific, legal, philosophical, economic, political, ethical and cultural factors that contribute to drug development. The pharmaceutical industry is under scrutiny to develop safer and more effective drugs in a quicker and more affordable manner. Recent criticism and debates have emphasized varying opinions on the issues concerning the drug discovery and development process. This book provides thoughtful and valuable discussions and analysis of the social challenges and potential opportunities through all stages of the pharmaceutical process, from inception through marketing. With a unique focus on the social factors that increasingly play a role in how drug development is planned, structured, and executed throughout the drug product lifecycle, this is an essential resource for students, professors, and researchers who seek a better understanding of the interface between the pharmaceutical industry, health care systems, and society. - Organized in a sequence of interrelated theories and principles that provide the foundation for increased understanding of the relevant social aspects - Includes analysis of important new advances, key scientific and strategic issues, and overviews of recent progress in drug development - Provides a global perspective with examples from developed areas, such as the US, Japan, Canada and Europe, as well as faster-growing and emerging economies including Brazil, Russia, India, and China - Serves as an essential resource for students, professors, and researchers who seek a better understanding of the interface between the pharmaceutical industry, health care systems, and society

Beyond Discovery

Author : Director of Commercialization College of Veterinary Medicine Jean E Schelhorn
Publisher : Oxford University Press
ISBN 13 : 0197512712
Total Pages : 209 pages
Book Rating : 4.1/5 (975 download)

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Book Synopsis Beyond Discovery by : Director of Commercialization College of Veterinary Medicine Jean E Schelhorn

Download or read book Beyond Discovery written by Director of Commercialization College of Veterinary Medicine Jean E Schelhorn and published by Oxford University Press. This book was released on 2022-01-14 with total page 209 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The book is a guide for academic researchers, especially scientists and engineers, on how to move their discoveries to the marketplace. Few academics understand what tech transfer is or how it works, and many shy away from it because they equate commercialization with starting a company. Yet those same individuals can be intrigued to learn of additional pathways that enable discoveries to be translated into marketable products or services. We help researchers explore multiple routes for commercialization, guides them through the personal decisions they must face, describes programs designed to help them, and provides advice to avoid common problems. We frame commercialization as the primary (often the only) way for research to solve societal problems. Impact can best be achieved if, a discovery leads to an invention/ that fills an unmet need in the marketplace. The range of entities that support technology transfer are described, and we offer best practices for researchers to maximize support the process. Engaging researchers effectively requires that institutions themselves adapt. Aligning commercialization with the rewards system is crucial, and integrating commercialization training into graduate and postdoctoral programs will produce the next generation of academic inventors. Furthermore, women and minorities face special challenges that must be overcome so that everyone's discovery receives support for commercialization. Woven through the book are profiles of academic inventors, which illustrate key points and help researchers to visualize themselves in such a role"--

Academic Entrepreneurship

Author : Michele Marcolongo
Publisher : John Wiley & Sons
ISBN 13 : 1118858964
Total Pages : 236 pages
Book Rating : 4.1/5 (188 download)

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Book Synopsis Academic Entrepreneurship by : Michele Marcolongo

Download or read book Academic Entrepreneurship written by Michele Marcolongo and published by John Wiley & Sons. This book was released on 2017-08-30 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: The pathway to bringing laboratory discoveries to market is poorly understood and generally new to many academics. This book serves as an easy-to-read roadmap for translating technology to a product launch – guiding university faculty and graduate students on launching a start-up company. • Addresses a growing trend of academic faculty commercializing their discoveries, especially those supported by the National Science Foundation and National Institutes of Health • Offers faculty a pathway and easy-to-follow steps towards determining whether their discovery / idea / technology is viable from a business perspective, as well as how to execute the necessary steps to create and launch a start-up company • Has a light-hearted and accessible style of a step-by-step guide to help graduate students, post-docs, and faculty learn how to go about spinning out their research from the lab • Includes interviews by faculty in the disciplines of materials science, pharmaceuticals, medical devices, information technology, energy, and mechanical devices – offering tips and discussing potential pitfalls to be avoided

Improving and Accelerating Therapeutic Development for Nervous System Disorders

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309292492
Total Pages : 107 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Improving and Accelerating Therapeutic Development for Nervous System Disorders by : Institute of Medicine

Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

Drugs

Author : Rick Ng
Publisher : John Wiley & Sons
ISBN 13 : 1118210700
Total Pages : 368 pages
Book Rating : 4.1/5 (182 download)

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Book Synopsis Drugs by : Rick Ng

Download or read book Drugs written by Rick Ng and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs." —Doody's Reviews, May 2009 "The second edition of a book that offers a user-friendly step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of preclinical trials." —Chemistry World, February 2009 The new edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. This second edition features many key enhancements, including Key Points, Chapter Summary, and Review Questions in each chapter, Answers to Review Questions provided in a book-end appendix, and one or two carefully selected "mini" case studies in each chapter. Richly illustrated throughout with over ninety figures and tables, this important book also includes helpful listings of current FDA and European guidelines and a special section on regulatory authority and processes in China. It is an indispensable resource for pharmaceutical industry and academic researchers, pharmaceutical managers and executives, healthcare clinicians, policymakers, regulators, and lobbyists with an interest in drug development. It is also an excellent textbook for students in pharmacy, science, and medicine courses.

A Fractured Profession

Author : David R. Johnson
Publisher : JHU Press
ISBN 13 : 1421423545
Total Pages : 192 pages
Book Rating : 4.4/5 (214 download)

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Book Synopsis A Fractured Profession by : David R. Johnson

Download or read book A Fractured Profession written by David R. Johnson and published by JHU Press. This book was released on 2017-10-16 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: Exploring the growing division among academic scientists over a profit motive in research. The commercialization of research is one of the most significant contemporary features of US higher education, yet we know surprisingly little about how scientists perceive and experience commercial rewards. A Fractured Profession is the first book to systematically examine the implications of commercialization for both universities and faculty members from the perspective of academic scientists. Drawing on richly detailed interviews with sixty-one scientists at four universities across the United States, sociologist David R. Johnson explores how an ideology of commercialism produces intraprofessional conflict in academia. The words of scientists themselves reveal competing constructions of status, conflicting norms, and divergent career paths and professional identities. Commercialist scientists embrace a professional ideology that emphasizes the creation of technologies that control societal uncertainties and advancing knowledge toward particular—and financial—ends. Traditionalist scientists, on the other hand, often find themselves embattled and threatened by university and federal emphasis on commercialization. They are less concerned about issues such as conflicts of interest and corruption than they are about unequal rewards, unequal conditions of work, and conflicts of commitment to university roles and basic science. Arguing that the division between commercialists and traditionalists represents a new form of inequality in the academic profession, this book offers an incisive look into the changing conditions of work in an era of academic capitalism. Focusing on how the profit motive is reshaping higher education and redefining what faculty are supposed to do, this book will appeal to scientists and academics, higher education scholars, university administrators and policy makers, and students considering a career in science.

The Role of NIH in Drug Development Innovation and Its Impact on Patient Access

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309498511
Total Pages : 103 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis The Role of NIH in Drug Development Innovation and Its Impact on Patient Access by : National Academies of Sciences, Engineering, and Medicine

Download or read book The Role of NIH in Drug Development Innovation and Its Impact on Patient Access written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-27 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.

Case Studies in Modern Drug Discovery and Development

Author : Xianhai Huang
Publisher : John Wiley & Sons
ISBN 13 : 1118219678
Total Pages : 488 pages
Book Rating : 4.1/5 (182 download)

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Book Synopsis Case Studies in Modern Drug Discovery and Development by : Xianhai Huang

Download or read book Case Studies in Modern Drug Discovery and Development written by Xianhai Huang and published by John Wiley & Sons. This book was released on 2012-04-19 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: Learn why some drug discovery and development efforts succeed . . . and others fail Written by international experts in drug discovery and development, this book sets forth carefully researched and analyzed case studies of both successful and failed drug discovery and development efforts, enabling medicinal chemists and pharmaceutical scientists to learn from actual examples. Each case study focuses on a particular drug and therapeutic target, guiding readers through the drug discovery and development process, including drug design rationale, structure-activity relationships, pharmacology, drug metabolism, biology, and clinical studies. Case Studies in Modern Drug Discovery and Development begins with an introductory chapter that puts into perspective the underlying issues facing the pharmaceutical industry and provides insight into future research opportunities. Next, there are fourteen detailed case studies, examining: All phases of drug discovery and development from initial idea to commercialization Some of today's most important and life-saving medications Drugs designed for different therapeutic areas such as cardiovascular disease, infection, inflammation, cancer, metabolic syndrome, and allergies Examples of prodrugs and inhaled drugs Reasons why certain drugs failed to advance to market despite major research investments Each chapter ends with a list of references leading to the primary literature. There are also plenty of tables and illustrations to help readers fully understand key concepts, processes, and technologies. Improving the success rate of the drug discovery and development process is paramount to the pharmaceutical industry. With this book as their guide, readers can learn from both successful and unsuccessful efforts in order to apply tested and proven science and technologies that increase the probability of success for new drug discovery and development projects.

Biotechnology Entrepreneurship

Author : Craig Shimasaki
Publisher : Academic Press
ISBN 13 : 0124047475
Total Pages : 489 pages
Book Rating : 4.1/5 (24 download)

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Book Synopsis Biotechnology Entrepreneurship by : Craig Shimasaki

Download or read book Biotechnology Entrepreneurship written by Craig Shimasaki and published by Academic Press. This book was released on 2014-04-08 with total page 489 pages. Available in PDF, EPUB and Kindle. Book excerpt: As an authoritative guide to biotechnology enterprise and entrepreneurship, Biotechnology Entrepreneurship and Management supports the international community in training the biotechnology leaders of tomorrow. Outlining fundamental concepts vital to graduate students and practitioners entering the biotech industry in management or in any entrepreneurial capacity, Biotechnology Entrepreneurship and Management provides tested strategies and hard-won lessons from a leading board of educators and practitioners. It provides a 'how-to' for individuals training at any level for the biotech industry, from macro to micro. Coverage ranges from the initial challenge of translating a technology idea into a working business case, through securing angel investment, and in managing all aspects of the result: business valuation, business development, partnering, biological manufacturing, FDA approvals and regulatory requirements. An engaging and user-friendly style is complemented by diverse diagrams, graphics and business flow charts with decision trees to support effective management and decision making. - Provides tested strategies and lessons in an engaging and user-friendly style supplemented by tailored pedagogy, training tips and overview sidebars - Case studies are interspersed throughout each chapter to support key concepts and best practices. - Enhanced by use of numerous detailed graphics, tables and flow charts

Innovation and Marketing in the Pharmaceutical Industry

Author : Min Ding
Publisher : Springer Science & Business Media
ISBN 13 : 1461478014
Total Pages : 763 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Innovation and Marketing in the Pharmaceutical Industry by : Min Ding

Download or read book Innovation and Marketing in the Pharmaceutical Industry written by Min Ding and published by Springer Science & Business Media. This book was released on 2013-10-31 with total page 763 pages. Available in PDF, EPUB and Kindle. Book excerpt: The pharmaceutical industry is one of today’s most dynamic and complex industries, involving commercialization of cutting-edge scientific research, a huge web of stakeholders (from investors to doctors), multi-stage supply chains, fierce competition in the race to market, and a challenging regulatory environment. The stakes are high, with each new product raising the prospect of spectacular success—or failure. Worldwide revenues are approaching $1 trillion; in the U.S. alone, marketing for pharmaceutical products is, itself, a multi-billion dollar industry. In this volume, the editors showcase contributions from experts around the world to capture the state of the art in research, analysis, and practice, and covering the full spectrum of topics relating to innovation and marketing, including R&D, promotion, pricing, branding, competitive strategy, and portfolio management. Chapters include such features as: · An extensive literature review, including coverage of research from fields other than marketing · an overview of how practitioners have addressed the topic · introduction of relevant analytical tools, such as statistics and ethnographic studies · suggestions for further research by scholars and students The result is a comprehensive, state-of-the-art resource that will be of interest to researchers, policymakers, and practitioners, alike.

Drug Discovery from Natural Products

Author : Olga Genilloud
Publisher : Royal Society of Chemistry
ISBN 13 : 1849733619
Total Pages : 435 pages
Book Rating : 4.8/5 (497 download)

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Book Synopsis Drug Discovery from Natural Products by : Olga Genilloud

Download or read book Drug Discovery from Natural Products written by Olga Genilloud and published by Royal Society of Chemistry. This book was released on 2012 with total page 435 pages. Available in PDF, EPUB and Kindle. Book excerpt: An integrated review of the most recent trends in natural products, drug discovery, and key lead candidates that are outstanding for their chemistry and biology in novel drug development.

Universities in the Marketplace

Author : Derek Bok
Publisher : Princeton University Press
ISBN 13 : 1400825490
Total Pages : 247 pages
Book Rating : 4.4/5 (8 download)

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Book Synopsis Universities in the Marketplace by : Derek Bok

Download or read book Universities in the Marketplace written by Derek Bok and published by Princeton University Press. This book was released on 2009-02-14 with total page 247 pages. Available in PDF, EPUB and Kindle. Book excerpt: Is everything in a university for sale if the price is right? In this book, one of America's leading educators cautions that the answer is all too often "yes." Taking the first comprehensive look at the growing commercialization of our academic institutions, Derek Bok probes the efforts on campus to profit financially not only from athletics but increasingly, from education and research as well. He shows how such ventures are undermining core academic values and what universities can do to limit the damage. Commercialization has many causes, but it could never have grown to its present state had it not been for the recent, rapid growth of money-making opportunities in a more technologically complex, knowledge-based economy. A brave new world has now emerged in which university presidents, enterprising professors, and even administrative staff can all find seductive opportunities to turn specialized knowledge into profit. Bok argues that universities, faced with these temptations, are jeopardizing their fundamental mission in their eagerness to make money by agreeing to more and more compromises with basic academic values. He discusses the dangers posed by increased secrecy in corporate-funded research, for-profit Internet companies funded by venture capitalists, industry-subsidized educational programs for physicians, conflicts of interest in research on human subjects, and other questionable activities. While entrepreneurial universities may occasionally succeed in the short term, reasons Bok, only those institutions that vigorously uphold academic values, even at the cost of a few lucrative ventures, will win public trust and retain the respect of faculty and students. Candid, evenhanded, and eminently readable, Universities in the Marketplace will be widely debated by all those concerned with the future of higher education in America and beyond.

Comprehensive Biomarker Discovery and Validation for Clinical Application

Author : Péter Horvatovich
Publisher : Royal Society of Chemistry
ISBN 13 : 1849734364
Total Pages : 385 pages
Book Rating : 4.8/5 (497 download)

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Book Synopsis Comprehensive Biomarker Discovery and Validation for Clinical Application by : Péter Horvatovich

Download or read book Comprehensive Biomarker Discovery and Validation for Clinical Application written by Péter Horvatovich and published by Royal Society of Chemistry. This book was released on 2013-06-17 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on proteomics biomarker discovery and validation procedures from the clinical perspective. It provides an overview of current technology and the challenges encountered throughout the process. This covers all key stages, from biomarker discovery and validation, through to registration with the European and US regulatory authorities (FDA and EMEA). All the important elements (such as patient selection, sample handling, data processing, and statistical analysis) are described in detail and the reader is introduced to each topic with well-described examples or guidelines for best practice. Case studies are also included to demonstrate clinical applications. Individual chapters explain the best performing techniques for profiling complex body fluids and biomarker discovery. This includes the application of mass spectrometry imaging combined with chromatography in profiling platforms and the use of laser micro dissection and MALDI imaging to study tissues in their natural environment. Future developments needed to improve the success rate of translating biomarker discovery into useful clinical tests are also discussed. Common pitfalls and success stories are described as are the limitations of the various technologies involved. Broad and interdisciplinary in approach, this book provides an excellent source of information for industrial and academic researchers, and those managing biobanks.

Rare Diseases and Orphan Products

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309158060
Total Pages : 442 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine

Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book 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.

Peptide Drug Discovery and Development

Author : Miguel Castanho
Publisher : John Wiley & Sons
ISBN 13 : 3527636749
Total Pages : 547 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Peptide Drug Discovery and Development by : Miguel Castanho

Download or read book Peptide Drug Discovery and Development written by Miguel Castanho and published by John Wiley & Sons. This book was released on 2011-10-24 with total page 547 pages. Available in PDF, EPUB and Kindle. Book excerpt: Filling a real knowledge gap, this handbook and ready reference is both modern and forward-looking in its emphasis on the "bench to bedside" translational approach to drug development. Clearly structured into three major parts, the book stakes out the boundaries of peptide drug development in the preclinical as well as clinical stages. The first part provides a general background and focuses on the characteristic strengths and weaknesses of peptide drugs. The second section contains five cases studies of peptides from diverse therapeutic fields, and the lessons to be learned from them, while the final part looks at new targets and opportunities, discussing several drug targets and diseases for which peptide drugs are currently being developed.

The Price of Global Health

Author : Ed Schoonveld
Publisher : Gower Publishing, Ltd.
ISBN 13 : 9781409420521
Total Pages : 384 pages
Book Rating : 4.4/5 (25 download)

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Book Synopsis The Price of Global Health by : Ed Schoonveld

Download or read book The Price of Global Health written by Ed Schoonveld and published by Gower Publishing, Ltd.. This book was released on 2011 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Price of Global Health is the first book of its kind: an in-depth but straightforward exploration of the pharmaceutical pricing strategy process, its underlying market access, general business and ethical considerations, and its implications for payers, physicians and patients. It is a much needed and invaluable resource for anybody interested, involved in or affected by the development, funding and use of prescription drugs. In particular, it is of critical importance to pharmaceutical company executives and other leaders and professionals in commercialization and drug development, including marketing, business development, market access and pricing, clinical development, drug discovery, regulatory affairs, health outcomes, market research and public affairs.

Modern Methods of Clinical Investigation

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309042860
Total Pages : 241 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Modern Methods of Clinical Investigation by : Institute of Medicine

Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.