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Publication: Metabolites

Abstract

Oral fluid testing offers a non-invasive alternative to blood sampling for monitoring drug exposure, but methods for detecting meloxicam and its metabolite in this matrix were not well established. This study developed and validated a fast LC-MS/MS method to detect and quantify meloxicam and its major metabolite, 5′-carboxymeloxicam, in oral fluid samples collected from 16 volunteers before and after a single meloxicam tablet dose, with pharmacokinetic parameters determined using Phoenix WinNonlin. The method demonstrated good linearity, accuracy, precision, and stability across relevant concentration ranges, and prostaglandin E2 was also successfully detected, demonstrating feasibility for combined PK/PD study designs. This validated oral fluid method offers a practical, minimally invasive tool for future meloxicam pharmacokinetic and pharmacodynamic research.

Author(s): Oliveira GM, Dionísio TJ, Siqueira‑Sandrin VS, Ferrari LAL, Colombini‑Ishikiriama BL, Faria FAC, Santos CF, Calvo AM

Published: June 15, 2023

Phoenix WinNonlin: PK From a Non-Invasive Matrix

Phoenix WinNonlin calculated pharmacokinetic parameters from oral fluid samples in this meloxicam study, supporting a less invasive alternative to blood-based PK/PD testing. Within a Phoenix platform now available through Phoenix Cloud, combining cloud speed with AI-powered workflows, Phoenix WinNonlin’s output can become submission-ready tables, figures, and listings through TFL Studio.

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