Blar i USN Open Archive på forfatter "Bernabe, Rosemarie de la Cruz"
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Ethics and the marketing authorization of pharmaceuticals: what happens to ethical issues discovered post-trial and pre-marketing authorization?
Bernabe, Rosemarie de la Cruz; van Thiel, Ghislaine J.M.W.; Breekveldt, Nancy S.; Gispen, Christine C.; van Delden, Johannes J.M. (Peer reviewed; Journal article, 2020)Background: In the EU, clinical assessors, rapporteurs and the Committee for Medicinal Products for Human Use are obliged to assess the ethical aspects of a clinical development program and include major ethical flaws in ... -
Regulatory oversight on the use of experimental therapies during a pandemic: The case of early access to convalescent plasma therapy in three LMICs
Bernabe, Rosemarie de la Cruz; Torres, Cristina E.; Wangge, Grace; Jimenez, Edlyn B.; Karbwang, Juntra (Peer reviewed; Journal article, 2021)Clinicians, especially in low- and middle-income countries (LMICs), contend with limited economic and healthcare resources in deciding appropriate and feasible care for their patients. Some of the LMICs affected by COVID-19 ...