European regulation on orphan medicinal products: 10 years of experience and future perspectives.

In 2000, regulation on orphan medicinal products was adopted in the European Union with the aim of benefiting patients who suffer from serious, rare conditions for which there is currently no satisfactory treatment. Since then, more than 850 orphan drug designations have been granted by the European Commission based on a positive opinion from the Committee for Orphan Medicinal Products (COMP), and more than 60 orphan drugs have received marketing authorization in Europe. Here, stimulated by the tenth anniversary of the COMP, we reflect on the outcomes and experience gained in the past decade, and contemplate issues for the future, such as catalysing drug development for the large number of rare diseases that still lack effective treatments.

A new approach for generic screening and quantitation of potential genotoxic alkylation compounds by pre-column derivatization and LC-MS/MS analysis.

A generic LC-MS/MS method was developed for the analysis of potentially genotoxic alkyl halides. A broad selection of alkyl halides were derivatized using 4-dimethylaminopyridine in acetonitrile. The reaction conditions for derivatization, i.

Management of atrial fibrillation: discrepancy between guideline recommendations and actual practice exposes patients to risk for complications.

Aims: To assess compliance to guidelines in the management of patients with atrial fibrillation.

Methods And Results: A total of 728 questionnaires were mailed to physicians with the intention of studying 'theoretical' compliance to practice guidelines. A retrospective evaluation of 200 records from consecutive patients hospitalized with atrial fibrillation was performed in order to verify 'actual' compliance to guidelines.

Malabsorption of hydrochlorothiazide following intestinal shunt surgery.

Hydrochlorothiazide 775mg was administered orally to 5 patients who had undergone intestinal shunt operations for obesity 1.5 to 6 years previously. Postoperative weight loss averaged 53.