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  2. Holtkamp F, Gudmundsdottir H, Maciulaitis R, Benda N, Thomson A, Vetter T. Change in Albuminuria and Estimated GFR as End Points for Clinical Trials in Early Stages of CKD: A Perspective From European Regulators. Am J Kidney Dis. 2019 Oct 25.
     
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  4. Potts J, Genov G, Segec A, Raine J, Straus S, Arlett P. Improving the Safety of Medicines in the EU: From signals to action. Clin Pharmacol Ther. 2019 Oct 17.
     
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  6. Weersink RA, Timmermans L, Monster-Simons MH, Mol PGM, Metselaar HJ, Borgsteede SD, Taxis K. Evaluation of Information in Summaries of Product Characteristics (SmPCs) on the Use of a Medicine in Patients With Hepatic Impairment. Front Pharmacol. 2019 Sep 17;10:1031.
     
  7. van Hunsel F, Gardarsdottir H, de Boer A, Kant A. Measuring the impact of pharmacovigilance activities, challenging but important. Br J Clin Pharmacol. 2019 Oct;85(10):2235-2237.
     
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  9. McGettigan P, Alonso Olmo C, Plueschke K, Castillon M, Nogueras Zondag D, Bahri P, Kurz X, Mol PGM. Patient Registries: An Underused Resource for Medicines Evaluation: Operational proposals for increasing the use of patient registries in regulatory assessments. Drug Saf. 2019 Nov;42(11):1343-1351. Erratum in: Drug Saf. 2019 Sep 5.
     
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  11. Bernabe RC, van Thiel GJMW, Breekveldt NS, Gispen CC, van Delden JJM. Regulatory sanctions for ethically relevant GCP violations. Drug Discov Today. 2019 Jul 6. pii: S1359-6446(19)30081-9.
     
  12. Haberkamp M, Moseley J, Athanasiou D, de Andres-Trelles F, Elferink A, Rosa MM, Magrelli A. European regulators' views on a wearable-derived performance measurement of ambulation for Duchenne muscular dystrophy regulatory trials. Neuromuscul Disord. 2019 Jul;29(7):514-516.
     
  13. Albrecht W, Kappenberg F, Brecklinghaus T, Stoeber R, Marchan R, Zhang M, Ebbert K, Kirschner H, Grinberg M, Leist M, Moritz W, Cadenas C, Ghallab A, Reinders J, Vartak N, van Thriel C, Golka K, Tolosa L, Castell JV, Damm G, Seehofer D, Lampen A, Braeuning A, Buhrke T, Behr AC, Oberemm A, Gu X, Kittana N, van de Water B, Kreiling R, Fayyaz S, van Aerts L, Smedsrød B, Ellinger-Ziegelbauer H, Steger-Hartmann T, Gundert-Remy U, Zeigerer A, Ullrich A, Runge D, Lee SML, Schiergens TS, Kuepfer L, Aguayo-Orozco A, Sachinidis A, Edlund K, Gardner I, Rahnenführer J, Hengstler JG. Prediction of human drug-induced liver injury (DILI) in relation to oral doses and blood concentrations. Arch Toxicol. 2019 Jun;93(6):1609-1637.
     
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  15. Denig P, van Puijenbroek EP, Soliman N, Mol PGM, de Vries ST. Adverse drug event patterns experienced by patients with diabetes: A diary study in primary care. Pharmacoepidemiol Drug Saf. 2019 Sep;28(9):1175-1179.
     
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  17. Dekker MJHJ, Bouvy JC, O'Rourke D, Thompson R, Makady A, Jonsson P, Gispen-de Wied CC. Alignment of European Regulatory and Health Technology Assessments: A Review of Licensed Products for Alzheimer's Disease. Front Med (Lausanne). 2019 May 7;6:73.
     
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  20. van der Laan JW, Benson CT, Janssens W, Bos J, Stahl E, Brady JT, Wändel-Liminga U, Corriol-Rohou S, Forster R, Hartmann A, Pertel PE, Robertson SM, Silva-Lima B, Malik RE, Chibout SD. Shared Learnings on the New EMA First-in-Human and Early Clinical Trial Guideline: Proceedings From a DIAlogue Session at DIA Europe 2018. Ther Innov Regul Sci. 2019 May 13:2168479019843514.
     
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