Dose-Finding Studies Among Orphan Drugs Approved in the EU: A Retrospective Analysis-Reference-Cited by-同舟云学术

Dose-Finding Studies Among Orphan Drugs Approved in the EU: A Retrospective Analysis

Published:2018-09-07 Issue:2 Volume:59 Page:229-244
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Schuller Yvonne¹^ORCID,Gispen-de Wied Christine²,Hollak Carla E. M.¹,Leufkens Hubertus G. M.³,Stoyanova-Beninska Violeta²

Affiliation:

1. Department of Endocrinology and Metabolism; Academic Medical Center; Meibergdreef Amsterdam The Netherlands

2. College ter Beoordeling Geneesmiddelen/Medicines Evaluation Board; Graadt van Roggenweg Utrecht The Netherlands

3. Division of Pharmacoepidemiology and Clinical Pharmacology; Department of Pharmaceutical Sciences; Utrecht Institute for Pharmaceutical Sciences; Utrecht University; Universiteitsweg Utrecht The Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/jcph.1304/fullpdf

Reference53 articles.

1. Report from Dose Finding Workshop . London: European Medicines Agency

2. Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999;Cross;Pharmacoepidemiol Drug Saf,2002

3. Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012;Sacks;JAMA,2014

4. Community register of orphan medicinal products for human use http://ec.europa.eu/health/documents/community-register/html/orphreg.htm

5. Treatment of Fabry disease: outcome of a comparative trial with agalsidase alfa or beta at a dose of 0.2 mg/kg;Vedder;PLoS One,2007

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