Excessive nitric oxide (NO) synthesis may be the critical link between the release of cellular mediators in the inflammatory cascade…
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Estimation of individual pharmacokinetic parameters in presence of possible non-compliance
In clinical trials, like ACTG 175 (Hammer, Katzenstein et al. 1996), drug levels in patients, if sampled at all, are…
Read moreLimitations of Population Approaches in Regulatory Assessment of New Chemical Entities
The theoretical principles behind population approaches during the clinical development of a new drug may be expected to result in…
Read moreClinical versus statistical significance in covariate selection
When carrying out population analyses on very large data sets the associated statistical power may necessitate the use of criteria…
Read moreDo we require the population approach to dose adjust in renal impairment? : A case study with dofetilide
For a drug or metabolite eliminated by renal mechanisms, impaired renal function (IRF) may alter its pharmacokinetics (PK) and pharamacodynamics…
Read moreSemi-Populational Model For Analysis Of Infusable Immunoglobulin-G Pharmacokinetics In VLBW Infants
Introduction: Infusable preparations of human immunoglobulin-G (IgG) have been considered for administration to premature very low birth weight (VLBW) infants…
Read moreComparison Of A Semiparametric Method With Nonmem For Population Analysis Of Simulated Data
Introduction: A semiparametric method of population analysis is described. This method differs from traditional methods of population analysis (eg NONMEM)…
Read moreThe analysis of ordinal pharmacodynamic data: applicationto allergy score.
We present preliminary analyses of a study investigating the association between a particular drug and allergic rhinitis. The data consist…
Read moreAn Automated Stepwise Covariate Model Building Procedure Within NONMEM
Model building techniques for identifying covariate relationships that have been used include: screening each covariate on each parameter, residual plots…
Read moreWhat Is The Relevance Of Estimating Inter-Study Variability In Population Pharmacokinetic Meta-Analysis?
Population pharmacokinetics is being increasingly applied to individual data collected in different studies without taking into account the random inter-study…
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