Browsing by Author "Leufkens, Hubert G."

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Exploring the Association between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: A VigiBase Study

Minnema, Lotte A.; Giezen, Thijs J.; Souverein, Patrick C.; Egberts, Toine C. G.; Leufkens, Hubert G. M.; Gardarsdottir, Helga (Springer Science and Business Media LLC, 2019-01-08)

Introduction: Several monoclonal antibodies (mAbs) have been linked to neuropsychiatric adverse efects in patients, including depression and suicidal ideation and behavior. Objective: The aim of this study was to quantify and characterize spontaneously ...
Reporting of quality attributes in scientific publications presenting biosimilarity assessments of (intended) biosimilars: a systematic literature review

Alsamil, Ali M.; Giezen, Thijs J.; Egberts, Toine C.; Leufkens, Hubert G.; Vulto, Arnold G.; van der Plas, Martijn R.; Gardarsdottir, Helga (Elsevier BV, 2020-11-01)

Last years, more than 46 unique biosimilars were approved by EMA and/or US-FDA following patent expiration of reference products. Biosimilars are not identical like generics, but highly similar versions where demonstrating biosimilarity of quality ...

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