Population pharmacokinetic modeling of dexmedetomidine nasal spray in Chinese adults.

ABSTRACT:

Objective

The main objective was to build and qualify a population pharmacokinetic (PopPK) model for dexmedetomidine nasal spray in Chinese adults and explore the covariates affecting the PopPK model parameters.

Methods

A population pharmacokinetic model was developed based on the results of 1,225 blood concentration points from 196 healthy volunteers (HV) and patients in phase I and phase III studies. Covariates significantly affecting pharmacokinetic characteristics were analyzed. Model selection was performed using nonlinear mixed-effects modeling (NONMEM), and covariates' screening was conducted using the traditional stepwise forward inclusion and backward elimination methods. Bootstrap and pcVPC methods were used for model validation. Logistic regression modeling was us

SUBMITTER: Huang Y 

PROVIDER: S-EPMC12436384 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature