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T Kerbusch

Publications and source records attributed to T Kerbusch.

20 records · Page 2Linked to original sources

Sensitive assay for pimozide in human plasma using high-performance liquid chromatography with fluorescence detection: application to pharmacokinetic studies.

A method is described for the measurement of pimozide in human plasma using HPLC with fluorescence detection. The method is specific and sensitive in the range of concentrations seen in human plasma after conventional dosing (1-15 ng/ml) with a limit of quantification of 1 ng/ml. The calibration curves are linear for concentrations between 1 and 50 ng/ml. Within-day and inter-day coefficients of variation are less than 7.4% and 15.5%, respectively, at three concentrations of pimozide (2, 10 and 20 ng/ml). Intra-day and inter-day bias are less than 18.5% and 12.5%, respectively. A pharmacokinetic study conducted in a healthy volunteer administered 6 mg of pimozide orally demonstrates the utility of this method.

Antipsychotic Agents↗

Planning for an adaptive design: a case study in COPD.

We discuss the practical and clinical considerations encountered when planning a Phase IIa trial in chronic obstructive pulmonary disease (COPD). Various adaptive strategies for reducing the cost of the trial and the statistical implications of these are explored. Use of the EAST software to evaluate the properties of the study designs with one or more interim analyses for futility, efficacy or either is described. We emphasize the rationale for choosing between alternative designs and the relationship between the clinical and statistical considerations.

Clinical Trials, Phase II as Topic↗