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European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences|April 23, 2025
Implementation of indication restrictions made by European regulatory action for antibiotics - amoxicillinAleksandra Opalska, Marcel Kwa, Hubert Leufkens
International Journal of Technology Assessment in Health Care|July 20, 2017
A DECADE OF HEALTH TECHNOLOGY ASSESSMENT IN POLANDIga Lipska, Neil McAuslane, Hubert Leufkens, et al.
Euro Surveillance : Bulletin Europeen Sur Les Maladies Transmissibles = European Communicable Disease Bulletin|November 13, 2020
Enabling appropriate use of antibiotics: review of European Union procedures of harmonising product information, 2007 to 2020Aleksandra Opalska, Marcel Kwa, Hubert Leufkens, et al.
Orphanet Journal of Rare Diseases|February 27, 2024
Trends in orphan medicinal products approvals in the European Union between 2010-2022Luísa Bouwman, Bruno Sepodes, Hubert Leufkens, et al.
Plos One|February 9, 2026
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 2023Luísa Bouwman, Hubert Leufkens, Bruno Sepodes, et al.
Drug Discovery Today|September 15, 2018
The future of drug development: the paradigm shift towards systems therapeuticsMeindert Danhof, Kevin Klein, Pieter Stolk, et al.
Therapeutic Innovation & Regulatory Science|February 3, 2020
A Proposed Framework for a Globally Applicable Pragmatic Approach to Using Facilitated Regulatory PathwaysLawrence Liberti, Neil McAuslane, Pieter Stolk, et al.
Drug Discovery Today|April 16, 2021
Regulatory density as a means to refine current regulatory approaches for increasingly complex medicinesKevin Klein, Pieter Stolk, Marie Louise De Bruin, et al.
Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research|June 19, 2018
Building Synergy between Regulatory and HTA Agencies beyond Processes and Procedures-Can We Effectively Align the Evidentiary Requirements? A Survey of Stakeholder PerceptionsTing Wang, Neil McAuslane, Lawrence Liberti, et al.
Nature Reviews. Drug Discovery|September 13, 2008
Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemmaHans-Georg Eichler, Francesco Pignatti, Bruno Flamion, et al.
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