Human Clinical Trials and Plasma Pharmacokinetics

Because of its spectrum of activity and unique mechanism of action, the Clinical Trials Evaluation Program of the United States National Cancer Institute initiated phase I clinical trials. To determine the pharmacokinetics of fos-triecin, a high-pressure liquid chromatographic method to measure fostriecin in plasma samples was developed (Pillon et al. 1994). Fostriecin is extracted from plasma samples with acetonitrile and then dichloromethane. It is then analyzed by HPLC with a mobile phase of 7.5% acetonitrile in 0.067 M phosphate buffer after separation on a reverse phase C18 column. The extraction efficiency is reported as 70% and the sensitivity limit 100 ng/ml.

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