Ethics and the marketing authorization of pharmaceuticals: what happens to ethical issues discovered post-trial and pre-marketing authorization?

Autor: Rosemarie D. L. C. Bernabe, Ghislaine J. M. W. van Thiel, Nancy S. Breekveldt, Christine C. Gispen, Johannes J. M. van Delden

Publikováno v: BMC Medical Ethics, Vol 21, Iss 1, Pp 1-8 (2020)

Abstract 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 the marketing authori

Externí odkaz: https://doaj.org/article/39b586aa966944d7bde67fb0fc8bd504

Ethics and the marketing authorization of pharmaceuticals: what happens to ethical issues discovered post-trial and pre-marketing authorization?

Autor: Christine C. Gispen, Johannes J. M. van Delden, Rosemarie D. L. C. Bernabe, Nancy S. Breekveldt, Ghislaine J. M. W. van Thiel

Publikováno v: BMC Medical Ethics
BMC Medical Ethics, Vol 21, Iss 1, Pp 1-8 (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 the marketing authorization de

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9fedbc442e5010ecf5ec75b6a426233a
https://pubmed.ncbi.nlm.nih.gov/33109181

Drug regulators and ethics : which GCP issues are also ethical issues?

Autor: Johannes J. M. van Delden, Nancy S. Breekveldt, Rosemarie D. L. C. Bernabe, Ghislaine J. M. W. van Thiel

Publikováno v: Drug Discovery Today, 21(2), 217. Elsevier Limited

Within the European Union (EU), good clinical practice (GCP) provides an ethical mandate to regulators; however, it is unclear what the content of that mandate is. By looking at the correspondence between GCP and ethical imperatives, we identify that

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::96800e9daaad3e05006c1d563d175455
https://dspace.library.uu.nl/handle/1874/343881

Treatment with inhaled corticosteroids in asthma is too often discontinued

Autor: Nancy S, Breekveldt-Postma, Jeroen, Koerselman, Joëlle A, Erkens, Thys, van der Molen, Jan-Willem J, Lammers, Ron M C, Herings, R M C, Herings

Publikováno v: Pharmacoepidemiology and Drug Safety, 17(4), 411-422. John Wiley and Sons Ltd
Breekveldt-Postma, N S, Koerselman, J, Erkens, J A, van der Molen, T, Lammers, J W, Herings, R M & Appendix, C S G L I T 2008, ' Treatment with inhaled corticosteroids in asthma is too often discontinued ', Pharmacoepidemiology and Drug Safety, vol. 17, no. 4, pp. 411-422 . https://doi.org/10.1002/pds.1552
Pharmacoepidemiology and Drug Safety, 17(4), 411-422. Wiley

Purpose To study persistence with inhaled corticosteroids (ICS) and its determinants in asthma-patients.Methods From the PHARMO database, asthma-patients (age = 2 dispensings in the first year were included. Persistence during the first year was defi

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::befa3677eda1d26e72c9ec1327a18acd
https://www.ncbi.nlm.nih.gov/pubmed/18205251

Extent of uncontrolled disease and associated medical costs in severe asthma – a PHARMO study.

Autor: Nancy S. Breekveldt-Postma, Joëlle A. Erkens, René Aalbers, Marjo J. T. van de Ven, Jan-Willem J. Lammers, Ron M. C. Herings

Publikováno v: Current Medical Research & Opinion; Apr2008, Vol. 24 Issue 4, p975-983, 9p