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Expert Opinion on Drug Safety
Volume 20, 2021 - Issue 11
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Original research
Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle – a focus on benefits and risks
Lourens T. Bloema Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands;b Pharmacovigilance department, Dutch Medicines Evaluation Board, Utrecht, The NetherlandsCorrespondence[email protected]
https://orcid.org/0000-0002-0014-8625View further author information
Mariana Karomia Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The NetherlandsView further author information
, Jarno Hoekmana Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands;c Pharmacovigilance department, Innovation Studies, Copernicus Institute of Sustainable Development, Utrecht University, Utrecht, The NetherlandsView further author information
, Menno E. van der Elstb Pharmacovigilance department, Dutch Medicines Evaluation Board, Utrecht, The NetherlandsView further author information
, Hubert G.M. Leufkensa Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The NetherlandsView further author information
, Olaf H. Klungela Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands;d Faculty of Health Sciences, University of Southern Denmark, Odense, DenmarkView further author information
& Aukje K. Mantel-Teeuwissea Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands
https://orcid.org/0000-0002-8782-0698View further author information
Pages 1433-1442
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Received 08 Apr 2021, Accepted 05 Jul 2021, Published online: 15 Jul 2021
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