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Signal detection and substantiation in view of the new Pharmacovigilance legislation - A. Pacuraiu

The new legislation reinforces the public health principle of monitoring medicinal products’ benefit-risk profile throughout...

Publicatie | 20-01-2017

Framework for model-based assessment of thyroid C-cell carcinogenicity by GLP-1 receptor agonists - W. van den Brink

It is unknown which factors are responsible for the development of C-cell carcinogenicity as observed by differences in thyroid...

Publicatie | 20-01-2017

Continuous innovation in the drug life cycle - J. Langedijk

Innovation may continue upon the approval of a new drug, for example through the licensing of new therapeutic indications or...

Publicatie | 20-01-2017

Biomarkers and tests of vaccine safety - C. de Wolf

Worldwide, millions of people are protected against various infectious diseases through vaccination. The need for new and...

Publicatie | 20-01-2017

The Evaluation of Drug Regulation - J. Bouvy

The European pharmaceutical market is strictly regulated. Sufficient levels of quality, safety, and efficacy will have to be...

Publicatie | 20-01-2017

Predictive value of animal studies in drug development - P. van Meer

Animal studies play an important role in the development of pharmaceuticals. Most studies are done to evaluate safety and are...

Publicatie | 20-01-2017

Qualitative analysis of the drug regulatory process concerning historical controlled trials - J. Nieuwenhuis

The use of historical controls (HCs) in clinical trials is poorly accepted from a regulatory perspective.

Publicatie | 20-01-2017

Not all commercially available tablet splitters are sufficiently accurate and precise to use in clin - M. Doeve

Breaking tablets in a reliable manner is essential for adequate and safe use of medicines. Therefore, from the health...

Publicatie | 20-01-2017

Dependence potential of psychotropic drugs - M. Bolscher

Previous research has shown animal models to be a valuable and highly valid predictor. However, sensitivity and specificity are...

Publicatie | 20-01-2017

Flexible Working Practices and Knowledge Worker Performance - N. van der Meulen

‘Work’ - and the way we work - is changing. Today’s workplace is invaded by information and communication technologies that are...

Publicatie | 20-01-2017