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Overview of withdrawals following consideration of patients’ interest 2017

The overview of withdrawals following consideration of patients’ interest 2017 states for which medicinal products the...

Publication | 22-09-2017

Product types and fees

The list of product types indicates the various product types handled by the MEB. The choice of the product type determines the...

Publication | 05-09-2017

MEB 47: Assessment criteria for combination packages

The Medicines Evaluation Board (MEB) has described the terms and conditions which are to be used to assess applications for...

Directive | 22-08-2017

On the Predictive Validity of Pre-Clinical Assessment of Dependence Potential - H. Lamberink

Animal studies on self-administration, physical dependence and drug discrimination are well established with high predictive...

Publication | 14-08-2017

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...

Publication | 14-08-2017

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...

Publication | 14-08-2017

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...

Publication | 14-08-2017

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...

Publication | 14-08-2017

Conditions of historical-controlled trials for anticancer treatments publication - Y. Yang

The difficulties of assessing historical controlled trials (HCTs) is noticed by regulators, thus investigation is warranted for...

Publication | 14-08-2017

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.

Publication | 14-08-2017