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Publication: Clinical Pharmacology in Drug Development

Abstract

No population pharmacokinetic model of valsartan existed for healthy Chinese subjects, despite the drug's widespread use for hypertension. This study retrospectively analyzed data from a bioequivalence study in 78 Chinese healthy subjects to build a population pharmacokinetic model using Phoenix NLME, examining demographic and biochemical covariates. Food affected the absorption rate constant, while liver enzymes (AST, ALT) and creatinine affected central compartment clearance in the final two-compartment model with absorption lag time. This first population pharmacokinetic study of valsartan in healthy Chinese subjects provides relevant reference parameters for future research on this widely used antihypertensive.

Author(s): Yang H, Gao R, Ji X, Wang Z, Qiu W

Published: 2022 年 10 月 26 日

Phoenix NLME:Reference Parameters for a Common Drug

Phoenix NLME built the first population PK model of valsartan in healthy Chinese subjects, identifying food and organ function as significant covariates. Phoenix NLME can be paired with Modeling Assistant, an AI copilot for model building and PML authoring, as part of a Phoenix platform built on more than 30 years of PK/PD expertise.

Find out more about Phoenix NLME

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