Evidence map›Paper›PMID 40210955›Full record

ArticlePediatric research2025

Precision dosing of amikacin in term neonates using pharmacometric approach.

Saikumar Matcha, Jaya Shree Dilli Batcha, Arun Prasath Raju, Bhim Bahadur Chaudhari, Sudheer Moorkoth, Surulivelrajan Mallayasamy, Leslie E Lewis

Abstract read
In one paragraph

Article in Pediatric research, 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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2citing papers in PubMed
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1 · What the graph read from it

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2 · The registry

The trial behind it

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3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

7 authors.

Saikumar MatchaResearch Scholar, Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India.
Jaya Shree Dilli BatchaResearch Scholar, Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India.
Arun Prasath RajuResearch Scholar, Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India.
Bhim Bahadur ChaudhariResearch Scholar, Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India.
Sudheer MoorkothProfessor & Head, Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India.
Surulivelrajan MallayasamyCenter for Pharmacometrics, Manipal Academy of Higher Education, Manipal, India. msv.rajan@manipal.edu.
Leslie E LewisProfessor & Head, Department of Pediatrics, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMaintaining amikacin concentrations within a specific therapeutic window is crucial to avoid sub-therapeutic or toxic levels. This study aimed to design a dosing nomogram for amikacin in neonates using a Population Pharmacokinetic (PopPK) modeling approach.

methodsPopPK model was developed using 101 amikacin concentrations from 80 neonates and validated using model diagnostics, and empirical Bayesian forecasting was performed. Pharmacokinetic profiles were simulated for virtual subjects with a range of covariates to identify suitable dosage regimens. Dosage regimens with the highest probability for the target group were selected to design the dosing nomogram.

resultsA two-compartment PK model best described the study data. Body weight (WT), serum creatinine (SCR), and post-natal age (PNA) affected the clearance of amikacin. The model predictions are with less than 15% absolute prediction error. WT and SCR were divided into five groups each, with each group repeated for every week of PNA for four weeks for dosing nomogram development.

conclusionA PopPK model was developed and successfully-predicted concentrations in the study population. This model was used to develop a nomogram considering significant covariates like WT, SCR, and PNA. The proposed dosing nomogram can assist clinicians in developing individualized dosage regimens. IMPACT: Population pharmacokinetic (PopPK) models for amikacin in term neonates were developed using clinical data from an Indian clinical setting and successfully-predicted the amikacin concentrations for the study population. Pharmacokinetic simulations with virtual subjects were used to calculate the probability of target attainment for different dosing regimens. The proposed dosing nomogram can potentially assist clinicians in designing optimal amikacin dosage regimens for neonates.

Indexed as

AmikacinAnti-Bacterial AgentsPrecision MedicineBayes TheoremBody WeightComputer SimulationCreatinineDose-Response Relationship, DrugFemaleHumansInfant, NewbornMaleModels, BiologicalNomogramsAmikacinAnti-Bacterial AgentsCreatinine

Identifiers

PMID40210955
PMCPMC12507653

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