Prediction of the Clearance of Eleven Drugs and Associated Variability in Neonates, Infants and Children

@article{Johnson2006PredictionOT,
  title={Prediction of the Clearance of Eleven Drugs and Associated Variability in Neonates, Infants and Children},
  author={T. Johnson and A. Rostami-Hodjegan and G. Tucker},
  journal={Clinical Pharmacokinetics},
  year={2006},
  volume={45},
  pages={931-956}
}
BackgroundPrediction of the exposure of neonates, infants and children to xenobiotics is likely to be more successful using physiologically based pharmacokinetic models than simplistic allometric scaling, particularly in younger children. However, such models require comprehensive information on the ontogeny of anatomical, physiological and biochemical variables; data that are not available from single sources.The Simcyp® software integrates demographic, genetic, physiological and pathological… Expand
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References

SHOWING 1-10 OF 166 REFERENCES
Prediction of Cytochrome P450-Mediated Hepatic Drug Clearance in Neonates, Infants and Children
TLDR
The aim of this commentary is to test and critically examine the proposed methods to estimate hepatic clearance (CL) as a function of age (0–20 years), with CYP3A-mediated metabolism as the case in point. Expand
Prediction of drug disposition in infants and children by means of physiologically based pharmacokinetic (PBPK) modelling: theophylline and midazolam as model drugs.
  • S. Björkman
  • Medicine
  • British journal of clinical pharmacology
  • 2005
TLDR
A general physiologically based pharmacokinetic (PBPK) model for drug disposition in infants and children, covering the age range from birth to adulthood, and to evaluate it with theophylline and midazolam as model drugs yielded results that generally tallied with literature data. Expand
Pharmacokinetics and Administration Regimens of Vancomycin in Neonates, Infants and Children
TLDR
The monitoring of serum vancomycin concentrations may be useful in selected neonatal and paediatric patient populations, especially where large interpatient variability occurs and administration guidelines are not clearly established. Expand
Physiologically Based Pharmacokinetic (PBPK) Modeling of Caffeine and Theophylline in Neonates and Adults: Implications for Assessing Children's Risks from Environmental Agents
TLDR
The current analysis utilizes data for caffeine and theophylline, closely related xanthines that are both cytochrome P-450 (CYP) 1A2 substrates, in developing PBPK models for neonates and adults, and a stepwise approach for modeling environmental toxicants in children is proposed. Expand
Prediction of drug clearance in children from adults: a comparison of several allometric methods.
  • I. Mahmood
  • Medicine
  • British journal of clinical pharmacology
  • 2006
TLDR
No single method is suitable for all drugs or for all age groups and a combination of approaches is suggested which may help in improving the prediction of clearance in children from adult data. Expand
Physiological Modeling of Age-Specific Changes in the Pharmacokinetics of Organic Chemicals in Children
TLDR
The PBPK model framework developed in this study should be useful for predicting the adult-children differences in internal dose of chemicals for risk assessment applications. Expand
Prediction of in vivo drug clearance from in vitro data. II: Potential inter-ethnic differences
TLDR
Only partial success in predicting ethnic differences in clearance indicates the need for larger and more reliable databases on relevant variables and in silico predictions might be used with more confidence to decrease theneed for repeating pharmacokinetic studies in different ethnic groups. Expand
Effect of maturation on drug disposition in pediatric patients.
Maturational changes in the physiologic processes that govern drug disposition in pediatric patients are described, and evaluation of data from pediatric drug studies is discussed. GastrointestinalExpand
Phenotyping of drug metabolism in infants and children: potentials and problems.
TLDR
There is almost no information about the maturation of polymorphic traits during ontogenesis, which has therapeutic implications in pediatrics, first, because several drug substrates of the polymorphic enzymes also are used in infants and children, and second, because for many such drugs, the treatment results may not be monitored by objective param-eters. Expand
Vancomycin Pharmacokinetics and Bayesian Estimation in Pediatric Patients
TLDR
NonMEM population modeling revealed that a weight-adjusted two-compartments model provided a better fit than a comparable one-compartment model and Bayesian estimation with either a single midinterval or trough sample has the potential to provide accurate and precise predictions of vancomycin concentrations. Expand
...
1
2
3
4
5
...