Analysis of Investigational Drugs in Biological Fluids. Method Development andRoutine Assay

摘要

Using the procedures described in this report, we were able to work sequentially or simultaneously on eleven projects: (1) WR 238,605, (2) halofantrine (and its metabolite), (3) WR 6026 (and its metabolites), (4) mefloquine (and its metabolite), (5) artelinic acid, (6) p-aminoheptanophenone (and related compounds), (7) primaquine (and its metabolite), (8) gentamicin and paromomycin, (9) pyridostigmine, (10) chloroquine (and its metabolites), and (11) a multiple drug interaction study in dog plasma for WR 238,605, mefloquine, chloroquine, quinine, doxycycline, and halofantrine with additional work on development and validation of LC/MS/MS methods for halofantrine (and its metabolite), WR 238,605 in terms of method development, validation, and characterization. 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).