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Rare Diseases and Orphan Products

Rare Diseases and Orphan Products
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 442
Release: 2011-04-03
Genre: Medical
ISBN: 0309158060

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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.


Creating R&D Incentives for Medicines for Neglected Diseases

Creating R&D Incentives for Medicines for Neglected Diseases
Author: Frank Müller-Langer
Publisher: Springer Science & Business Media
Total Pages: 312
Release: 2009-09-30
Genre: Business & Economics
ISBN: 3834983233

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Virtually no research is targeted at developing medicines for tropical diseases as the expected market returns from R&D into these diseases in the private pharmaceuticals sector are too low. Frank Müller-Langer addresses the market failure with respect to R&D for medicines for tropical diseases and the lack of short-term access to affordable medicines in poor countries. The author analyzes additional push and pull mechanisms to stimulate R&D for pharmaceutical products alongside patent protection which may help mitigate the problem of those consumers in poor countries who lack access to affordable medicines. Furthermore, he reasons that a global regime of banning parallel trade from low-income countries to high-income countries is desirable from a developing country’s perspective.


Strong Medicine

Strong Medicine
Author: Michael Kremer
Publisher: Princeton University Press
Total Pages: 167
Release: 2016-05-31
Genre: Business & Economics
ISBN: 0691171165

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From Nobel Prize–winning economist Michael Kremer and fellow leading development economist Rachel Glennerster, an innovative solution for providing vaccines in poor countries Millions of people in the third world die from diseases that are rare in the first world—diseases like malaria, tuberculosis, and schistosomiasis. AIDS, which is now usually treated in rich countries, still ravages the world's poor. Vaccines offer the best hope for controlling these diseases and could dramatically improve health in poor countries. But developers have little incentive to undertake the costly and risky research needed to develop vaccines. This is partly because the potential consumers are poor, but also because governments drive down prices. In Strong Medicine, Michael Kremer and Rachel Glennerster offer an innovative yet simple solution to this worldwide problem: "Pull" programs to stimulate research. Here's how such programs would work. Funding agencies would commit to purchase viable vaccines if and when they were developed. This would create the incentives for vaccine developers to produce usable products for these neglected diseases. Private firms, rather than funding agencies, would pick which research strategies to pursue. After purchasing the vaccine, funders could distribute it at little or no cost to the afflicted countries. Strong Medicine details just how these legally binding commitments would work. Ultimately, if no vaccines were developed, such a commitment would cost nothing. But if vaccines were developed, the program would save millions of lives and would be among the world's most cost-effective health interventions.


Modern Medicine

Modern Medicine
Author: Pronobesh Chattopadhyay
Publisher: CRC Press
Total Pages: 263
Release: 2024-05-02
Genre: Medical
ISBN: 1040018386

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Modern Medicine: Biomedical Devices, Medical Gases, Radiopharmaceuticals, New Drug Discovery, Volume 2 discusses the procedures of drug approval and regulatory requirements that must be met according to the United States Food and Drug Administration (FDA), the European Medical Agency (EMA), and the Central Drug Standard Control Organization (CDSCO). In the rapidly evolving landscape of modern medicine, groundbreaking innovations have emerged that are reshaping the way we approach healthcare. Modern Medicine delves into the cutting-edge realms of medical devices, medical gases, radiopharmaceuticals, and new drug discovery, offering a comprehensive exploration of these transformative fields that are revolutionizing patient care and medical practices. Discover the future of healthcare technology, and uncover the intricate world of biomedical engineering, where state-of-the-art devices seamlessly merge with the human body to monitor, diagnose, and treat ailments Dive deep into the utilization of medical gases for respiratory conditions, pain management, and even novel applications in regenerative medicine Unravel the mysteries of radiopharmaceuticals, a fusion of molecular imaging and therapy that offers unprecedented insights into the inner workings of the human body Embark on a journey through the intricate processes of drug discovery, where groundbreaking research and cutting-edge technologies are yielding therapies that were once deemed impossible Modern Medicine is a must-read for medical professionals, researchers, students, and anyone intrigued by the remarkable intersection of science, technology, and patient well-being. Join us on a journey to the forefront of medical innovation, where the unimaginable becomes reality, and the future of healthcare takes shape before our eyes. The chapter on regulatory implications for the approval process in this book will be the most useful resource for researchers and students, particularly those with backgrounds in pharma, forensic medicine, regulatory affairs, or those who aspire to succeed in drug research. Additionally, the information contained in this volume of the book could be of great interest to researchers working in the pharmaceutical and health industries.


Preventing Medication Errors and Improving Drug Therapy Outcomes

Preventing Medication Errors and Improving Drug Therapy Outcomes
Author: Charles D. Hepler
Publisher: CRC Press
Total Pages: 464
Release: 2003-02-25
Genre: Medical
ISBN: 0203010736

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Read this book in order to learn: Why medicines often fail to produce the desired result and how such failures can be avoided How to think about drug product safety and effectiveness How the main participants in a medications use system can improve outcomes and how professional and personal values, attitudes, and ethical reasoning fit into


Translational Cancer Research for Surgeons, An Issue of Surgical Oncology Clinics

Translational Cancer Research for Surgeons, An Issue of Surgical Oncology Clinics
Author: William G. Cance
Publisher: Elsevier Health Sciences
Total Pages: 311
Release: 2013-10-28
Genre: Medical
ISBN: 0323227457

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This issue of the Surgical Oncology Clinics of North America, Guest Edited by Dr. William G. Cance, is devoted to Translational Cancer Research for Surgeons. Translational Cancer research aims to move bench research to the bedside by applying basic science toward potential therapies. This issue will present the concepts of translational research and development of targeted therapeutics, and its implications for surgeons. It will show clinical applications for surgeons regarding sarcoma/GIST, melanoma, colorectal cancer, breast cancer, and endocrine cancer.


FDA Consumer

FDA Consumer
Author:
Publisher:
Total Pages: 260
Release: 1999
Genre: Consumer protection
ISBN:

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Translational Orthopedics

Translational Orthopedics
Author: Jeffrey A. Bakal
Publisher: Elsevier
Total Pages: 580
Release: 2024-04-26
Genre: Science
ISBN: 0323885624

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Translational Orthopedics: Designing and Conducting Translational Research covers the principles of evidence-based medicine and applies these principles to the design of translational investigations. The reader will come to fully understand important concepts including case-control study, prospective cohort study, randomized trial, and reliability study. Medical researchers will benefit from greater confidence in their ability to initiate and execute their own investigations, avoid common pitfalls in translational orthopedics, and know what is needed in collaboration. Further, this title is an indispensable tool in grant writing and funding efforts. The practical, straightforward approach helps the aspiring investigator navigate challenging considerations in study design and implementation. The book provides valuable discussions of the critical appraisal of published studies in translational orthopedics, allowing the reader to learn how to evaluate the quality of such studies with respect to measuring outcomes and to make effective use of all types of evidence in patient care. In short, this practical guidebook will be of interest to every Medical Researcher or Orthopedist who has ever had a good clinical idea but not the knowledge of how to test it. Focuses on the principles of evidence-based medicine and applies these principles to the design of translational investigations within orthopedics Provides a practical, straightforward approach that helps investigators navigate challenging considerations in study design and implementation Details discussions of the critical appraisal of published studies in translational orthopedics, supporting evaluation with respect to measuring outcomes and making effective use of all types of evidence in patient care


Race in a Bottle

Race in a Bottle
Author: Jonathan Kahn
Publisher: Columbia University Press
Total Pages: 330
Release: 2013
Genre: Medical
ISBN: 0231162987

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Approved by the FDA in 2005 as the first drug with a race-specific indication on its label, BiDil was touted as a pathbreaking therapy to treat heart failure in black patients. Kahn reveals that, at the most basic level, BiDil became racial through legal maneuvering and commercial pressure as much as through medical understandings of how the drug worked. He examines the legal and calls for a more reasoned approach to using race in biomedical research and practice.