261 documents
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...
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...
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...
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...
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...
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...
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...
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...
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...
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.