Adverse events in MS patients fulfilling or not inclusion criteria of the respective clinical trial - The problem of generalizability.

Background: The aim of this study was to evaluate how many MS patients treated with an approved DMD in routine care would have fulfilled the inclusion and exclusion criteria of phase III clinical trial and would therefore be eligible for the respective drug trial. Further, adverse events and disease progression for these patients were compared.

Methods: A comparison of patients fulfilling phase III clinical trial inclusion and exclusion criteria and those who do not with regard to sociodemographic and clinical characteristics, adverse events and disease progression.

Effect of applying inclusion and exclusion criteria of phase III clinical trials to multiple sclerosis patients in routine clinical care.

Background: Newly approved, drug-modifying therapies are associated with still unknown adverse events, although clinical trials leading to approval have strict inclusion and exclusion criteria and analyse safety and efficacy.

Objectives: The aim of this study was to analyse the eligibility of multiple sclerosis (MS) patients treated in routine care into the phase III clinical trial of the respective drug.

Methods: In total, 3577 MS patients with 4312 therapies were analysed.

Population pharmacokinetics of vancomycin in patients with external ventricular drain-associated ventriculitis.

Background: To determine the distribution of vancomycin into the cerebrospinal fluid (CSF) in patients with external ventricular drain (EVD)-associated ventriculitis, the pharmacokinetics of vancomycin were evaluated and covariate relationships explored.

Methods: For the population pharmacokinetic model patients were recruited in a neurocritical care unit at the University Hospital of Muenster in the period between January 2014 and June 2015. All patients had a clinical evidence of EVD-associated ventriculitis.