Orphan Drugs and Rare Diseases

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Read or download book entitled Orphan Drugs and Rare Diseases written by David C Pryde and published by Royal Society of Chemistry in PDF, EPUB and Kindle Format. Click Get This Book button to download or read online books. Join over 650.000 happy Readers and READ as many books as you like. We cannot guarantee that Orphan Drugs and Rare Diseases book is available in the library.

  • Publisher : Royal Society of Chemistry
  • Release : 09 December 2022
  • ISBN : 9781849738064
  • Page : 488 pages
  • Rating : 4.5/5 from 103 voters

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This book provides an up-to-date monograph on the drug discovery and regulatory elements of therapuetics used to treat rare or orphan diseases.

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Orphan Drugs and Rare Diseases

Orphan Drugs and Rare Diseases
  • Author : David C Pryde,Michael J Palmer
  • Publisher : Royal Society of Chemistry
  • Release Date : 2014
  • ISBN : 9781849738064
GET THIS BOOKOrphan Drugs and Rare Diseases

This book provides an up-to-date monograph on the drug discovery and regulatory elements of therapuetics used to treat rare or orphan diseases.

Orphan Drugs

Orphan Drugs
  • Author : Elizabeth Hernberg-Ståhl,Miroslav Reljanovic
  • Publisher : Woodhead Publishing
  • Release Date : 2018-11-13
  • ISBN : 0081013590
GET THIS BOOKOrphan Drugs

This authoritative and comprehensive book makes the reader familiar with the processes of bringing orphan drugs to the global market. There are between 5,000 and 7,000 rare diseases and the number of patients suffering from them is estimated to be more than 50 million in the US and Europe. Before the orphan drug legislation enacted in the US in 1983, there was a limited interest from industry to develop treatment for very small patient groups. One of the difficulties is, of course, that similar

Rare Diseases and Orphan Drugs

Rare Diseases and Orphan Drugs
  • Author : Jules J. Berman
  • Publisher : Academic Press
  • Release Date : 2014-05-26
  • ISBN : 9780124200098
GET THIS BOOKRare Diseases and Orphan Drugs

Rare Diseases and Orphan Drugs shows that much of what we now know about common diseases has been achieved by studying rare diseases. It proposes that future advances in the prevention, diagnosis, and treatment of common diseases will come as a consequence of our accelerating progress in the field of rare diseases. Understanding the complex steps in the development of common diseases, such as cancer, cardiovascular disease, and metabolic diseases, has proven a difficult problem. Rare diseases, however, are often

Rare Diseases and Orphan Products

Rare Diseases and Orphan Products
  • Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
  • Publisher : National Academies Press
  • Release Date : 2011-04-03
  • ISBN : 9780309158060
GET THIS BOOKRare Diseases and Orphan Products

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.

Orphan Diseases and Orphan Drugs

Orphan Diseases and Orphan Drugs
  • Author : I. Herbert Scheinberg,J. M. Walshe
  • Publisher : Manchester University Press
  • Release Date : 1989-04
  • ISBN : 0719022967
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Orphan Drugs

Orphan Drugs
  • Author : Elizabeth Hernberg-Ståhl,Miroslav Reljanović
  • Publisher : Elsevier
  • Release Date : 2013-11-15
  • ISBN : 9781908818393
GET THIS BOOKOrphan Drugs

This authoritative and comprehensive book makes the reader familiar with the processes of bringing orphan drugs to the global market. There are between 5,000 and 7,000 rare diseases and the number of patients suffering from them is estimated to be more than 50 million in the US and Europe. Before the orphan drug legislation enacted in the US in 1983, there was a limited interest from industry to develop treatment for very small patient groups. One of the difficulties is, of course, that similar

Orphan Drugs and Rare Diseases

Orphan Drugs and Rare Diseases
  • Author : David C Pryde,Michael J Palmer
  • Publisher : Royal Society of Chemistry
  • Release Date : 2014-07-30
  • ISBN : 9781782624202
GET THIS BOOKOrphan Drugs and Rare Diseases

Orphan drugs are designated drug substances that are intended to treat rare or ‘orphan’ diseases. More than 7000 rare diseases are known that collectively affect some 6-7% of the developed world’s population; however, individually, any single, rare disease may only affect a handful of people making them commercially unattractive for the biopharmaceutical industry to target. Ground breaking legislation, starting with the Orphan Drug Act that was passed in the US in 1983 to provide financial incentives for companies to develop orphan

Breakthrough Business Models

Breakthrough Business Models
  • Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation,Robert Giffin,Sally Robinson,Theresa Wizemann
  • Publisher : National Academies Press
  • Release Date : 2009-02-17
  • ISBN : 9780309178167
GET THIS BOOKBreakthrough Business Models

The process for developing new drug and biologic products is extraordinarily expensive and time-consuming. Although large pharmaceutical companies may be able to afford the cost of development because they can expect a large return on investment, organizations developing drugs to treat rare and neglected diseases are unable to rely on such returns. On June 23, 2008, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held a public workshop, "Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and

Orphan Drug Amendments of 1991

Orphan Drug Amendments of 1991
  • Author : United States. Congress. Senate. Committee on Labor and Human Resources
  • Publisher : Unknown
  • Release Date : 1992
  • ISBN : PSU:000020339968
GET THIS BOOKOrphan Drug Amendments of 1991

Anticompetitive Abuse of the Orphan Drug Act

Anticompetitive Abuse of the Orphan Drug Act
  • Author : United States. Congress. Senate. Committee on the Judiciary. Subcommittee on Antitrust, Monopolies, and Business Rights
  • Publisher : Unknown
  • Release Date : 1992
  • ISBN : PSU:000019987705
GET THIS BOOKAnticompetitive Abuse of the Orphan Drug Act

Orphan Drug Act

Orphan Drug Act
  • Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment
  • Publisher : Unknown
  • Release Date : 1990
  • ISBN : UCR:31210014697658
GET THIS BOOKOrphan Drug Act

Orphan Drug Law Matures into Medical Mainstay

Orphan Drug Law Matures into Medical Mainstay
  • Author : Anonim
  • Publisher : DIANE Publishing
  • Release Date : 2022-12-09
  • ISBN : 1422326772
GET THIS BOOKOrphan Drug Law Matures into Medical Mainstay

Orphan Drug Reauthorization

Orphan Drug Reauthorization
  • Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment
  • Publisher : Unknown
  • Release Date : 1994
  • ISBN : UCR:31210013511751
GET THIS BOOKOrphan Drug Reauthorization

Global Pediatric Development of Drugs, Biologics, and Medical Devices

Global Pediatric Development of Drugs, Biologics, and Medical Devices
  • Author : Jocelyn Jennings,Linda McBride
  • Publisher : Unknown
  • Release Date : 2021-11-26
  • ISBN : 1947493736
GET THIS BOOKGlobal Pediatric Development of Drugs, Biologics, and Medical Devices

Innovative Methods for Rare Disease Drug Development

Innovative Methods for Rare Disease Drug Development
  • Author : Shein-Chung Chow
  • Publisher : CRC Press
  • Release Date : 2020-11-11
  • ISBN : 9781000208337
GET THIS BOOKInnovative Methods for Rare Disease Drug Development

In the United States, a rare disease is defined by the Orphan Drug Act as a disorder or condition that affects fewer than 200,000 persons. For the approval of "orphan" drug products for rare diseases, the traditional approach of power analysis for sample size calculation is not feasible because there are only limited number of subjects available for clinical trials. In this case, innovative approaches are needed for providing substantial evidence meeting the same standards for statistical assurance as drugs used