Analysis of Investigational Drugs in Biological Fluids- Method Development and Analysis of Pre-Clinical and Clinical Samples.
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 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), chioroquine (and its metabolites, monodesethylchloroquine and didesethyldiloroquine), WR 243,251, WR 238,605, quinine, doxycycline, and artelinic acid. Work on routine analyses of biological specimens during this period was performed for studies that required determination of concentrations of WR 238,605, mefloquine, chioroquine (and its metabolites, monodesethylchloroquine and didesethyldiloroquine), doxycycline, halofantrine (and its metabolite, WR 178,460), and quinine. 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, 1999
- Accession Number
- ADA373375
Entities
People
- Emil T. Lin
Organizations
- University of California, San Francisco