Safety population size and duration of exposure prior to approval of new medicines: A database analysis of medicines centralised approved in the European Union between 2011 and 2023

• Luísa Bouwman ,

  Roles Formal analysis, Methodology, Writing – original draft

  * E-mail: mlbouwman@edu.ulisboa.pt

  Affiliations Faculdade de Farmácia, Universidade de Lisboa, Lisboa, Portugal, Laboratory of Systems Integration Pharmacology, Clinical and Regulatory Science, Research Institute for Medicines of the University of Lisbon (iMED.ULisboa), Lisboa, Portugal

  https://orcid.org/0000-0003-3098-6774

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• Hubert Leufkens,

  Roles Supervision, Writing – review & editing

  Affiliations Faculdade de Farmácia, Universidade de Lisboa, Lisboa, Portugal, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands

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• Bruno Sepodes,

  Roles Supervision, Writing – review & editing

  Affiliations Faculdade de Farmácia, Universidade de Lisboa, Lisboa, Portugal, Laboratory of Systems Integration Pharmacology, Clinical and Regulatory Science, Research Institute for Medicines of the University of Lisbon (iMED.ULisboa), Lisboa, Portugal

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• Carla Torre

  Roles Supervision, Writing – review & editing

  Affiliations Faculdade de Farmácia, Universidade de Lisboa, Lisboa, Portugal, Laboratory of Systems Integration Pharmacology, Clinical and Regulatory Science, Research Institute for Medicines of the University of Lisbon (iMED.ULisboa), Lisboa, Portugal

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