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Therapeutic Innovation & Regulatory Science|February 5, 2021
A Decade of Marketing Authorization Applications of Anticancer Drugs in the European Union: An Analysis of Procedural TimelinesMarjolein Garsen, Maaike Steenhof, Alex ZwiersFrontiers in Medicine|August 1, 2026
Clinical evidence deficiencies drive CHMP negative opinions and pre-opinion withdrawals in the EU centralized procedure (2021-2025)Iris Pennings, Prerona Boruah, Alex ZwiersFrontiers in Pharmacology|February 5, 2026
Trends in oncology marketing applications in the European Union: a five-year systematic reviewRicardo Basto, Siddartha Karaya, Alex ZwiersClinical and Translational Science|April 4, 2023
Clinical development time is shorter for new anticancer drugs approved via accelerated approval in the US or via conditional approval in the EUEbru Demirci, Grace Omes-Smit, Alex ZwiersTherapeutic Innovation & Regulatory Science|August 11, 2021
Healthy Volunteer Studies in the Development of Anticancer Drugs with Genotoxic FindingsGrace Omes-Smit, Marjolein Garsen, Alex ZwiersClinical and Translational Science|May 13, 2022
A detailed analysis of expedited regulatory review time of marketing authorization applications for new anticancer drugs in the US and EUFabiany da Costa Gonçalves, Ebru Demirci, Alex ZwiersHuman Gene Therapy|April 21, 2025
Advancing Potency Assay Development for Advanced Therapy Medicinal Products: A Comprehensive Approach and Regulatory InsightsAlaa Abdellatif, Melissa Bou Jaoudeh, Alex Zwiers, et al.Clinical Drug Investigation|November 12, 2010
Assessment of the potential for displacement interactions with sugammadex: a pharmacokinetic-pharmacodynamic modelling approachAlex Zwiers, Michiel van den Heuvel, Jean Smeets, et al.Therapeutic Innovation & Regulatory Science|January 13, 2021
Implementation of Quality by Design (QbD) Principles in Regulatory Dossiers of Medicinal Products in the European Union (EU) Between 2014 and 2019Judith P Ter Horst, Sada L Turimella, Frans Metsers, et al.Thrombosis Research|May 19, 2023
OKL-1111, A modified cyclodextrin as a potential universal reversal agent for anticoagulantsJoost C M Meijers, Kamran Bakhtiari, Alex Zwiers, et al.Pageof 2