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- Jacoline C. Bouvy, Hans C. Ebbers, H Schellekens, Mark A Koopmanschap
- Clinical pharmacology and therapeutics
- 2013
We analyzed the cost-effectiveness of all Periodic Safety Update Reports (PSURs) submitted for biologicals in Europe from 1995 to 2009 by comparing two regulatory scenarios: full regulation (PSUR… (More)
- Jacoline C. Bouvy, Mark A Koopmanschap, Rashmi R Shah, H Schellekens
- Clinical pharmacology and therapeutics
- 2012
We analyzed the cost-effectiveness of the International Conference on Harmonisation (ICH) E14 guideline that requires a thorough QT/QTc (TQT) study for all drugs under development. We compared two… (More)
- Wouter P. C. Boon, Ellen H. M. Moors, Arjen Meijer, H Schellekens
- Clinical pharmacology and therapeutics
- 2010
The need for fast drug innovation and the public demand for risk-free drugs creates a dilemma for regulatory authorities: less restrictive procedures involve uncertainties about benefit/risk profiles… (More)
- H Schellekens, David Khayat
- Journal of clinical oncology : official journal…
- 2004
8224 Background: Patents of innovator biopharmaceutical products, such as epoetin, are starting to expire allowing biosimilar versions of these products to eventually enter European and American… (More)