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Qualification opinion of novel methodologies in the predementia stage of Alzheimer's disease: cerebro-spinal-fluid related biomarkers for drugs affecting amyloid burden--regulatory considerations by European Medicines Agency focusing in improving benefit/risk in regulatory trials.
Isaac M, Vamvakas S, Abadie E, Jonsson B, Gispen C, Pani L. Isaac M, et al. Among authors: gispen c. Eur Neuropsychopharmacol. 2011 Nov;21(11):781-8. doi: 10.1016/j.euroneuro.2011.08.003. Epub 2011 Sep 7. Eur Neuropsychopharmacol. 2011. PMID: 21903360
The ambivalent place of ethics in European regulatory documents.
Bernabe RDLC, van Thiel GJMW, Gispen CC, Breekveldt NS, van Delden JJM. Bernabe RDLC, et al. Among authors: gispen cc. Drug Discov Today. 2018 Feb;23(2):205-207. doi: 10.1016/j.drudis.2017.10.011. Epub 2017 Oct 27. Drug Discov Today. 2018. PMID: 29081355 Free article. No abstract available.
Regulatory sanctions for ethically relevant GCP violations.
Bernabe RC, van Thiel GJMW, Breekveldt NS, Gispen CC, van Delden JJM. Bernabe RC, et al. Among authors: gispen cc. Drug Discov Today. 2019 Nov;24(11):2116-2119. doi: 10.1016/j.drudis.2019.07.001. Epub 2019 Jul 6. Drug Discov Today. 2019. PMID: 31288094 Free article.
Outcomes of parathyroidectomy versus calcimimetics for secondary hyperparathyroidism and kidney transplantation: a propensity-matched analysis.
Koh EY, van der Plas WY, Dulfer RR, Pol RA, Kruijff S, Rotmans JI, Appelman-Dijkstra N, Schepers A, de Borst MH, Hoorn EJ, van Ginhoven TM, Nieveen van Dijkum EJM, Vogt L, Engelsman AF; Dutch Hyperparathyroidism Study Group. Koh EY, et al. Langenbecks Arch Surg. 2020 Sep;405(6):851-859. doi: 10.1007/s00423-020-01953-5. Epub 2020 Aug 11. Langenbecks Arch Surg. 2020. PMID: 32778916