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Gecombineerde hormonale anticonceptiva die ethinylestradiol bevatten: Nederlandse vertaling SmPC en patiëntenbijsluiter

De CMDh heeft een SmPC- en patiëntenbijsluitertekst vastgesteld voor de farmacodynamische interactie bij gelijktijdig gebruik...

Publicatie | 25-01-2017

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...

Publicatie | 20-01-2017

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...

Publicatie | 20-01-2017

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...

Publicatie | 20-01-2017

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...

Publicatie | 20-01-2017

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...

Publicatie | 20-01-2017

Drug therapy for onchocerciasis - A. Klink

Worldwide roughly 18 million people are infected with Onchocerca volculus, of which 3 to 4 million people have skin disease and...

Publicatie | 20-01-2017

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...

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