Analysis of Investigational Drugs in Biological Fluids - Method Development and Analysis of Pre-Clinical and Clinical Samples
Annual rept. 11 Aug 1999-10 Aug 2000
CALIFORNIA UNIV SAN FRANCISCO
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Using the procedures described in this report, we were able to work sequentially or simultaneously on development, validation and characterization of assays for WR 6026 and its metabolites, WR 211789 and WR 254421, mefloquine and its metabolite, WR 160972, p-aminoheptanophenone and related compounds, WR 242511, halofantrine and its metabolite, WR 178,460, and their stereoisomers, chloroquine and its metabolites, monodesethylchloroquine and didesethylchloroquine, WR 243,251, WR 238,605, doxycycline, gentamicin, paromomycin and artelinic add. Work on routine analyses of biological specimens during this period was performed for studies that required determination of concentrations of artelinic acid, gentamicin and paromomycin. We worked on demonstrating sensitivity, specificity, linearity, lack of interferences, accuracy, and reproducibility of the analytical method, describing the extent of recovery for the method, and reporting on the stability of compounds of interest in specimens during storage and drug analysis to provide documentation in support of Investigational New Drug IND submissions to the Food and Drug Administration FDA.