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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

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

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

Regulatory Challenges of Biopharmaceuticals - H.C. Ebbers

The safety profile of biopharmaceuticals may be affected by seemingly minor changes in the production process. This makes them...

Publicatie | 20-01-2017

Marketing authorisation of new medicines in the EU: towards evidence-based improvement - M. Putzeist

The current marketing authorisation system of medicinal products has been criticized for its’ demanding requirements and high...

Publicatie | 20-01-2017

Predicting and improving individual long-term outcome in patients with diabetes and nephropathy - F. Holtkamp

Therapy with agents intervening with the Renin-Angiotensin-Aldosterone-System (RAAS) are considered a cornerstone in reducing...

Publicatie | 20-01-2017