Analysis of Investigational Drugs in Biological Fluids-Method Development.
Abstract
Using the procedures described in this report, we were able to work sequentially or simultaneously on development, validation and characterization of assays for WR 238,605 (and its stereoisomers), halofantrine (and its metabolite and their stereoisomers), WR 6026 (and its metabolites), mefloquine (and its metabolite), artelinic acid, p-aminoheptanophenone (and related compounds), gentamicin and paromomycin, pyridostigmine, WR 242511, chloroquine (and its metabolites), WR 243,251, quinine and doxycycline. Work on routine analyses of biological specimens during this period was performed for studies that required determination of concentrations of WR 238,605 (and its stereoisomers), halofantrine (and its metabolite and their stereoisomers), WR 6026 (and its metabolites), mefloquine, p-aminoheptanophenone (and related compounds), primaquine, gentamicin and paromomycin, chloroquine (and its metabolites), quinine, and doxycycline. 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).
Document Details
- Document Type
- Technical Report
- Publication Date
- Sep 01, 1998
- Accession Number
- ADA356020
Entities
People
- Emil T. Lin
Organizations
- University of California, San Francisco