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CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 8, August 2026.ABSTRACT The accelerated development of innovative anticancer therapies has led to the early approval of an increasing number of drugs. However, clinical evidence available at the time of approval is often limited, necessitating additional post‐marketing studies to supplement safety and efficacy data.
Aina Tsuno, Hiroe Kitagaki, Hideki Maeda
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Orphan drugs, orphan diseases. The first decade of orphan drug legislation in the EU
European Journal of Clinical Pharmacology, 2012To assess the methodological quality of Orphan Medicinal Product (OMP) dossiers and discuss possible reasons for the small number of products licensed.Information about orphan drug designation, approval, refusal or withdrawal was obtained from the website of the European Medicines Agency and from the European Public Assessment Reports.From 2000 up to ...
Roberta, Joppi +2 more
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2018
Rare diseases represent a group of conditions affecting a very limited number of patients. Low profitability resulting from the small size of target population coupled with difficulties in conducting the research causes the lack of interest from the pharmaceutical industry.
Daria, Korchagina +3 more
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Rare diseases represent a group of conditions affecting a very limited number of patients. Low profitability resulting from the small size of target population coupled with difficulties in conducting the research causes the lack of interest from the pharmaceutical industry.
Daria, Korchagina +3 more
openaire +2 more sources
Radiopharmaceuticals as orphan drugs
Seminars in Nuclear Medicine, 1996Rare diseases and conditions are defined as diseases or conditions that affect less than 200,000 individuals in the United States. Because of the limited population suffering from any given rare disorder, there is little economic motivation for the development of drug products for its diagnosis or treatment.
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Orphan drugs—or orphan diseases?
1988In the beginning, the question was that of how to provide drugs for rare diseases; and the beginning in this country was perhaps around 1972 when the ‘Pharmaceutical Working Party’ of the National Economic Development Office discussed the matter and agreed to keep it under review [1].
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[Orphan drugs and orphan diseases].
Revista de neurologia, 2002To define the concepts of orphan drugs and diseases, the current situation of clinical investigation of them, the attitude of the pharmaceutical industry and aspects of health legislation, especially in the European Community.We review the history of orphan drugs, the name used for those drugs, apparatus, biological agents and dietetic preparations ...
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