From promising molecules to orphan drugs: Early clinical drug development
Author:
Affiliation:
1. Department of Clinical Pharmacology, University Hospitals Leuven
Publisher
International Research and Cooperation Association for Bio & Socio-Sciences Advancement (IRCA-BSSA)
Subject
General Medicine
Link
https://www.jstage.jst.go.jp/article/irdr/6/1/6_2016.01094/_pdf
Reference24 articles.
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3. 3. Kesselheim AS, Myers JA, Avorn J. Characteristics of clinical trials to support approval of orphan vs nonorphan drugs forcancer. JAMA. 2011; 305:2320-2326.
4. 4. Bell SA, Tudur Smith C. A comparison of interventional clinical trials in rare versus non-rare diseases: An analysis of ClinicalTrials.gov. Orphanet J Rare Dis. 2014; 9:170-180.
5. 5. Francillon A, Pickering G, Belorgey C. Exploratory clinical trials: Implementation modes & guidelines, scope and regulatory fFramework. Therapie. 2009; 64:155-159.
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