ArticleDrug design, development and therapy2025
Physiologically Based Pharmacokinetic Modeling and Dose Optimization of Linezolid in Pediatric Patients With Renal Impairment.
Article in Drug design, development and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- Physiologically based pharmacokinetic modeling of cefotaxime to inform pediatric dosing in renal impairment.European journal of clinical pharmacology · 2026Article
- From Population-Based PBPK to Individualized Virtual Twins: Clinical Validation and Applications in Medicine.Journal of clinical medicine · 2026Review
Corrections and comments
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Authors and funding
7 authors.
Funding
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Abstract
Objective: Linezolid (LZD), a commonly used antimicrobial agent in clinical practice, has not undergone adequate pharmacokinetic (PK) assessment in pediatric populations with renal impairment (RI). Physiologically based pharmacokinetic (PBPK) modeling provides unique benefits for investigating drug pharmacokinetics in specific patient groups. This study aimed to employ the PBPK model to refine and optimize the therapeutic dosing protocol of LZD for RI pediatric patients. Methods: The model was developed and validated for both healthy adults and RI adults, which was subsequently adapted for pediatric applications. Upon verification of the pediatric Based on clinical PK data and real-world study findings, the PBPK model demonstrated precise prediction of LZD exposure in pediatric populations with varying degrees of RI, encompassing weight- and age-associated PK variations. Results: The PBPK modeling simulations exhibited robust agreement with observational data for LZD across both oral and intravenous delivery routes under diverse dosing protocols, as evidenced by the fold error (FE) always between 0.5 and 2 times, geometric mean fold error (GMFE) was less than 2.0 and mean absolute prediction error (MAPE) was within 100%. Pediatric populations with severe or end-stage RI exhibited 1.21-fold and 1.28-fold elevations in plasma concentration-time curve (AUC) values, respectively, relative to healthy pediatric counterparts when administered equivalent 10 mg/kg LZD doses. Pharmacodynamic analysis confirmed that the proposed dosing regimens-8 mg/kg every 8 hours for children with severe or end-stage RI -were effective in achieving the target AUC Conclusion: Our model provides a predictive instrument to enhance precision in determining therapeutic LZD dosage regimens for pediatric populations through systematic integration of developmental PK parameters.
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