Literature DB >> 26841744

Post-authorisation assessment of orphan drugs.

Carla E M Hollak1, Marieke Biegstraaten2, Marcel Levi3, Rob Hagendijk4.   

Abstract

Mesh：

Year:  2015        PMID： 26841744     DOI： 10.1016/S0140-6736(15)00827-2

Source DB:  PubMed          Journal:  Lancet        ISSN： 0140-6736            Impact factor:   79.321


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  4 in total

1.  Design of a framework for the deployment of collaborative independent rare disease-centric registries: Gaucher disease registry model.

Authors:  Matthew I Bellgard; Kathryn R Napier; Alan H Bittles; Jeffrey Szer; Sue Fletcher; Nikolajs Zeps; Adam A Hunter; Jack Goldblatt
Journal:  Blood Cells Mol Dis       Date:  2017-01-27       Impact factor: 3.039

2.  Remodeling an existing rare disease registry to be used in regulatory context: Lessons learned and recommendations.

Authors:  Marina Mordenti; Manila Boarini; Fabio D'Alessandro; Elena Pedrini; Manuela Locatelli; Luca Sangiorgi
Journal:  Front Pharmacol       Date:  2022-09-23       Impact factor: 5.988

3.  Registries supporting new drug applications.

Authors:  Carla J Jonker; H Marijke van den Berg; Marcel S G Kwa; Arno W Hoes; Peter G M Mol
Journal:  Pharmacoepidemiol Drug Saf       Date:  2017-10-06       Impact factor: 2.890

4.  Oncologic orphan drugs approved in the EU - do clinical trial data correspond with real-world effectiveness?

Authors:  Yvonne Schuller; Marieke Biegstraaten; Carla E M Hollak; Heinz-Josef Klümpen; Christine C Gispen-de Wied; Violeta Stoyanova-Beninska
Journal:  Orphanet J Rare Dis       Date:  2018-11-28       Impact factor: 4.123
  4 in total

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