Population pharmacokinetics of levamisole in children with steroid-sensitive nephrotic syndrome.

Aim: The aim was to investigate the population pharmacokinetics of levamisole in children with steroid-sensitive nephrotic syndrome.

Methods: Non-linear mixed effects modelling was performed on samples collected during a randomized controlled trial. Samples were collected from children who were receiving 2.

The influence of the European paediatric regulation on marketing authorisation of orphan drugs for children.

Background: Drug development for rare diseases is challenging, especially when these orphan drugs (OD) are intended for children. In 2007 the EU Paediatric Drug Regulation was enacted to improve the development of high quality and ethically researched medicines for children through the establishment of Paediatric Investigation Plans (PIPs). The effect of the EU Paediatric Drug Regulation on the marketing authorisation (MA) of drugs for children with rare diseases was studied.

Roll out of intraveneous artesunate under named patient programmes in the Netherlands, Belgium and France.

Background: Intravenous (IV) artesunate is the treatment of choice for severe malaria. In Europe, this treatment is only available in a few countries via named patient programmes (NPPs). As a case study, the legal and organisational aspects and pharmacovigilance of these NPPs and possibilities for harmonisation within the EU were studied over time and space using IV artesunate (Malacef) in the Netherlands, Belgium and France.

Manual blood exchange transfusion does not significantly contribute to parasite clearance in artesunate-treated individuals with imported severe Plasmodium falciparum malaria.

Background: Exchange transfusion (ET) has remained a controversial adjunct therapy for the treatment of severe malaria. In order to assess the relative contribution of ET to parasite clearance in severe malaria, all patients receiving ET as an adjunct treatment to parenteral quinine or to artesunate were compared with patients treated with parenteral treatment with quinine or artesunate but who did not receive ET. ET was executed using a standardized manual isovolumetric exchange protocol.

Development and evaluation of age-appropriate film-coated tablets of levamisole for paediatric use (2 - 18 years).

Objectives: To develop an oral solid dosage form of levamisole suitable for the paediatric population in terms of dose accuracy, palatability, stability and ease of administration.

Methods: Small undividable tablets (Ø5 - 8 mm) in four different strengths were manufactured to allow for flexible and accurate dosing. In vitro dissolution testing was used to determine drug release in different media.