259 documents
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.
The development of a test battery to study the relationship between older people’s hand-eye function - L. Donkerbroek
Tablet subdivision is an inaccurate practice, due to the often purely aesthetic division lineresulting in potential medication...
Additional Monitoring of Medicines & Social Media - M. van der Sar
The list of medicines under additional monitoring was published 25 April 2013 by the European Medicines Agency and consist of...
Interchangeability of Generic Anti-epileptic Drugs: a Quantitative Analysis - N. Banishki
Authorization of generic products depends on proof of bioequivalence comparing generics with the innovator. Regulations do not...