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Orphan Drugs - Understanding the Rare Disease Market and its Dynamics (Hardcover, New)
Loot Price: R4,438
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Orphan Drugs - Understanding the Rare Disease Market and its Dynamics (Hardcover, New)
Series: Woodhead Publishing Series in Biomedicine
Expected to ship within 12 - 17 working days
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Total price: R4,458
Discovery Miles: 44 580
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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 levels of investment
are needed from a pharmaceutical company to bring a drug to the
market for both small and large patient groups.
The journey from application of an orphan drug designation to a
reimbursed market- approved drug is long and many obstacles occur
during the journey.
After reading the book, readers will: Understand who the
players/stakeholders are in the rare orphan disease field and their
specific needs and concerns: patients and patient organizations,
researchers and treating physicians within the field, industry,
regulatory and reimbursement bodies* Understand the strong
partnership between the different players and the various
initiatives to improve and increase access to treatment for
patients; minimizing the gap between numbers of known diseases,
orphan designations, approved drugs and paid drugs.
The book also provides short practical case stories from patients
and researchers, as well as representatives from industry and
authorities on the challenges they came across in developing orphan
drugs or getting access to orphan drugs.
A comprehensive overview of strategy, key activities and
considerations of how to bring an orphan drug from concept to the
market and make it available to patientsA source of updated
information, news and trends for those who are already active in
this fast-evolving fieldCovers the global definitions and the
criteria for getting an orphan drug designation in, for example,
the US and Europe
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