Pre‐approval and post‐approval availability of evidence and clinical benefit of conditionally approved cancer drugs in Europe: A comparison with standard approved cancer drugs-Reference-Cited by-同舟云学术

Pre‐approval and post‐approval availability of evidence and clinical benefit of conditionally approved cancer drugs in Europe: A comparison with standard approved cancer drugs

Published:2022-01-05 Issue: Volume: Page:
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Brit J Clinical Pharma

Author:

Bloem Lourens T.¹²^ORCID,Bot Rosa E.¹²,Mantel‐Teeuwisse Aukje K.¹,Elst Menno E.²,Sonke Gabe S.²³,Klungel Olaf H.¹⁴,Leufkens Hubert G. M.¹,Hoekman Jarno¹⁵

Affiliation:

1. Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences Utrecht University Utrecht the Netherlands

2. Dutch Medicines Evaluation Board Utrecht the Netherlands

3. Department of Medical Oncology Netherlands Cancer Institute Amsterdam the Netherlands

4. Faculty of Health Sciences University of Southern Denmark Odense Denmark

5. Innovation Studies, Copernicus Institute of Sustainable Development Utrecht University Utrecht the Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.15141

Reference35 articles.

1. Postauthorization changes to specific obligations of conditionally authorized medicines in the European Union: a retrospective cohort study;Bloem LT;Clin Pharmacol Ther,2019

2. Characteristics of preapproval and postapproval studies for drugs granted accelerated approval by the US Food and Drug Administration;Naci H;JAMA,2017

3. European Medicines Agency.CHMP Guideline on the scientific application and the practical arrangements necessary to implement Commission Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 (EMA/CHMP/509951/2006 Rev. 1). 25 February2016.

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