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  2. van Riet-Nales DA, Sundberg K, de Boer A, Hirschlérova B. Developing patient-centric medicines for older people: Reflections from the draft EMA paper on the pharmaceutical development of medicines for use in the older population. Br J Clin Pharmacol. 2020 Oct;86(10):2008-2013. doi: 10.1111/bcp.14530.
     
  3. Francisca RDC, Baba E, Hoeve CE, Zomerdijk IM, Sturkenboom MCJM, Straus SMJM. Introduction or Discontinuation of Additional Risk Minimisation Measures During the Life Cycle of Medicines in Europe. Drug Saf. 2020 Sep 30. doi: 10.1007/s40264-020-00993-6.
     
  4. Santoro A, Caplanusi I, Sweeney F, Cappelli B, Nolan L, Straus S, Arlett P. Navigating stormy waters: 10 years of operation of the European Union Regulatory Network Incident Management Plan for Medicines for Human Use. Pharmacoepidemiol Drug Saf. 2020 Sep 21. doi: 10.1002/pds.5133.
     
  5. van Meer P, Theunissen P, van den Hoorn T, Herberts C, van der Laan JW. Animal-free applications in the development of cell-based therapies. Br J Clin Pharmacol. 2020 Sep 15. doi: 10.1111/bcp.14544.
     
  6. van Marum RJ. Underrepresentation of the elderly in clinical trials, time for action. Br J Clin Pharmacol. 2020 Oct;86(10):2014-2016. doi: 10.1111/bcp.14539. Epub 2020 Sep 9.
     
  7. Glerum PJ, Neef C, Burger DM, Yu Y, Maliepaard M. Pharmacokinetics and Generic Drug Switching: A Regulator's View. Clin Pharmacokinet. 2020 Sep;59(9):1065-1069. doi: 10.1007/s40262-020-00909-8. 
     
  8. Ghalandari N, Dolhain RJEM, Hazes JMW, van Puijenbroek EP, Kapur M, Crijns HJMJ. Intrauterine Exposure to Biologics in Inflammatory Autoimmune Diseases: A Systematic Review. Drugs. 2020 Aug 27. doi: 10.1007/s40265-020-01376-y.
     
  9. Ismail RK, Schramel FMNH, van Dartel M, Hilarius DL, de Boer A, Wouters MWJM, Smit HJM; Dutch Lung Cancer Audit Scientific Committee. The Dutch Lung Cancer Audit: Nationwide quality of care evaluation of lung cancer patients. Lung Cancer. 2020 Aug 21;149:68-77. doi: 10.1016/j.lungcan.2020.08.011. 
     
  10. van den Hoorn T, Nakchedi T, de Wolf ACMT, Pasmooij AMG, van der Laan JW, Herberts CA. Mining scientific advice reports on cell-based products; insight in the non-clinical development program. Br J Clin Pharmacol. 2020 Aug 13. doi: 10.1111/bcp.14515. 
     
  11. Moscetti L, Hennik P, Bolstad B, Camarero J, Josephson F, Melchiorri D, Sommerfelt Grønvold M, Sjoberg J, Botezatu M, Mulder J, Meulendijks D, Trullas Jimeno A, Zafiropoulos N, Bergh J, Enzmann H, Pignatti F. Combinations in the first-line treatment of patients with advanced/metastatic renal cell cancer: regulatory aspects. ESMO Open. 2020 Aug;5(4):e000856. doi: 10.1136/esmoopen-2020-000856. 
     
  12. Althunian TA, de Boer A, Mantel-Teeuwisse AK, Groenwold RHH, Gispen-de Wied CC, Leufkens HGM, Klungel OH. Assessment of the Regulatory Dialogue Between Pharmaceutical Companies and the European Medicines Agency on the Choice of Noninferiority Margins. Clin Ther. 2020 Aug;42(8):1588-1594. doi: 10.1016/j.clinthera.2020.06.004. 
     
  13. Ferreira GS, Veening-Griffioen DH, Boon WPC, Moors EHM, van Meer PJK. Levelling the Translational Gap for Animal to Human Efficacy Data. Animals (Basel). 2020 Jul 15;10(7):1199. doi: 10.3390/ani10071199. 
     
  14. Glerum PJ, Maliepaard M, de Valk V, Burger DM, Neef K. Drug switching in the Netherlands: a cohort study of 20 active substances. BMC Health Serv Res. 2020 Jul 13;20(1):650. doi: 10.1186/s12913-020-05494-x. 
     
  15. Jonker CJ, Oude Rengerink K, Hoes AW, Mol PGM, van den Berg HM. Inhibitor development in previously untreated patients with severe haemophilia: A comparison of included patients and outcomes between a clinical study and a registry-based study. Haemophilia. 2020 Jul 6. doi: 10.1111/hae.14100. 
     
  16. de Vries E, Denig P, de Vries ST, Monster TBM, Hugtenburg JG, Mol PGM. Drug Safety Issues Covered by Lay Media: A Cohort Study of Direct Healthcare Provider Communications Sent between 2001 and 2015 in The Netherlands. Drug Saf. 2020 Jul;43(7):677-690. doi: 10.1007/s40264-020-00922-7. 
     
  17. Karapinar-Çarkit F, van den Bemt PMLA, Sadik M, van Soest B, Knol W, van Hunsel F, van Riet-Nales DA. Opportunities for changes in the drug product design to enhance medication safety in older people: Evaluation of a national public portal for medication incidents. Br J Clin Pharmacol. 2020 Oct;86(10):1946-1957. doi: 10.1111/bcp.14392. 
     
  18. Veening-Griffioen DH, Ferreira GS, Boon WPC, Gispen-de Wied CC, Schellekens H, Moors EHM, Van Meer PJK. Tradition, not science, is the basis of animal model selection in translational and applied research. ALTEX. 2020 Jun 22. doi: 10.14573/altex.2003301. 
     
  19. van Zeijl MCT, Ismail RK, de Wreede LC, van den Eertwegh AJM, de Boer A, van Dartel M, Hilarius DL, Aarts MJB, van den Berkmortel FWPJ, Boers-Sonderen MJ, de Groot JB, Hospers GAP, Kapiteijn E, Piersma D, van Rijn RS, Suijkerbuijk KPM, Ten Tije AJ, van der Veldt AAM, Vreugdenhil G, Haanen JBAG, Wouters MWJM. Real-world outcomes of advanced melanoma patients not represented in phase III trials. Int J Cancer. 2020 Jun 19. doi: 10.1002/ijc.33162.