Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs
نویسندگان
چکیده
منابع مشابه
Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs
OBJECTIVES The research and development process in the field of rare diseases is characterised by many well-known difficulties, and a large percentage of orphan medicinal products do not reach the marketing approval.This work aims at identifying orphan medicinal products that failed the developmental process and investigating reasons for and possible factors influencing failures. DESIGN Drugs...
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ژورنال
عنوان ژورنال: BMJ Open
سال: 2017
ISSN: 2044-6055,2044-6055
DOI: 10.1136/bmjopen-2017-017358