ReviewCurrent clinical pharmacology2014
Pharmacokinetic studies in infants using minimal-risk study designs.
Review in Current clinical pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07120971 (A Phase 0/Phase 1 Trial of Metformin for Premature Infants With Bronchopulmonary Dysplasia), which is not on this map. Cited by 19 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 0/Phase 1 Trial of Metformin for Premature Infants With Bronchopulmonary Dysplasia
Who cites it
19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 28 citations in OpenAlex.
- Clinical pharmacology of cytotoxic drugs in neonates and infants: Providing evidence-based dosing guidance.European journal of cancer (Oxford, England : 1990) · 2022Pooled it
- A descriptive systematic review of salivary therapeutic drug monitoring in neonates and infants.British journal of clinical pharmacology · 2018Pooled it
- Population pharmacokinetic modeling and simulation-informed ceftazidime dosing in Chinese neonates using quantitative dried blood spot micro-sampling.Antimicrobial agents and chemotherapy · 2026Article
- Predicting Ketamine Exposure in Pediatric Status Epilepticus: A Pharmacokinetic-Machine Learning Approach.European journal of drug metabolism and pharmacokinetics · 2026Article
- Pharmacokinetic Monitoring of JAK Inhibitor and Tacrolimus for Safe and Effective Management of Graft-Versus-Host Disease After Pediatric Liver Transplantation.Pediatric transplantation · 2025Article
- Sources of pharmacokinetic and pharmacodynamic variability and clinical pharmacology studies of antiseizure medications in the pediatric population.Clinical and translational science · 2024Review
- A point-of-care pharmacokinetic/pharmacodynamic trial in critically ill children: Study design and feasibility.Contemporary clinical trials communications · 2023Article
- Dried Blood Spots in Neonatal Studies: A Computational Analysis for the Role of the Hematocrit Effect.Pharmaceuticals (Basel, Switzerland) · 2023Article
- An exploration on retro-construction of plasma drug concentration-time curves from corresponding urine excretion data and single-point plasma concentrations using a simplified and idealized method.Translational pediatrics · 2023Article
- Perinatal tuberculosis-An approach to an under-recognized diagnosis.Frontiers in public health · 2023Review
- Review of Scavenged Sampling for Sustainable Therapeutic Drug Monitoring: Do More With Less.Therapeutic drug monitoring · 2022Review
- IRB Decision-Making about Minimal Risk Research with Pregnant Participants.Ethics & human research · 2021Article
- Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial): A Randomized Controlled Trial: Background, Aims and Study Protocol.Frontiers in pain research (Lausanne, Switzerland) · 2021Article
- Model-Informed Bayesian Estimation Improves the Prediction of Morphine Exposure in Neonates and Infants.Therapeutic drug monitoring · 2020Article
- Creation of a Multicenter Pediatric Inpatient Data Repository Derived from Electronic Health Records.Applied clinical informatics · 2019Article
- Innovative Study Designs Optimizing Clinical Pharmacology Research in Infants and Children.Journal of clinical pharmacology · 2018Review
- Salivary Diagnostics in Pediatrics: Applicability, Translatability, and Limitations.Frontiers in public health · 2017Review
- New antibiotic dosing in infants.Clinics in perinatology · 2015Review
- Ethics of drug research in the pediatric intensive care unit.Paediatric drugs · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 1 institution in 1 country.
Funding
Abstract
Infants are therapeutic orphans. Many drugs used in infants are used "off-label", increasing the risk of drug toxicity and suboptimal efficacy in this vulnerable population. This knowledge gap in clinical pharmacology is partly attributed to challenges associated with conducting clinical trials in infants. Consequently, there is a need for novel and efficient study designs more suited to this population. Available literature describing the use of minimal-risk approaches to characterize the pharmacokinetics (PK) of drugs in infants was critically reviewed. Population PK approach with sparse sampling was found to be well established. Other, more recent alternatives, like dried blood spots sampling, opportunistic design, and the use of non-blood matrices are promising strategies with an increasing number of applications in infants. Physiologically based pharmacokinetic modeling provides valuable insight in drug disposition but still needs more prospective validation. Increasing experience with these methods provides understanding of their strengths and limitations and will help improve the design of future PK studies in infants.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.