ReviewThe AAPS journal2005
Pharmacodynamic parameter estimation: population size versus number of samples.
Review in The AAPS journal, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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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.
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Who cites it
10 citing papers in PubMed.
- Pharmacokinetic/Pharmacodynamic Modeling of the Acute Heart Rate Effects of Delta-9 Tetrahydrocannabinol and Its Major Metabolites After Intravenous Injection in Healthy Volunteers.European journal of drug metabolism and pharmacokinetics · 2025Article
- Predicting Antibiotic Effect of Vancomycin Using Pharmacokinetic/Pharmacodynamic Modeling and Simulation: Dense Sampling versus Sparse Sampling.Antibiotics (Basel, Switzerland) · 2022Article
- Population Pharmacodynamic Modeling Using the Sigmoid EThe AAPS journal · 2020Article
- Impact of Sampling Period on Population Pharmacokinetic Analysis of Antibiotics: Why do You Take Blood Samples Following the Fourth Dose?Pharmaceuticals (Basel, Switzerland) · 2020Article
- Feasibility of Exposure-Response Analyses for Clinical Dose-Ranging Studies of Drug Combinations.The AAPS journal · 2018Article
- Parameter estimation for sigmoid ETranslational and clinical pharmacology · 2017Article
- Combined Use of Etomidate and Dexmedetomidine Produces an Additive Effect in Inhibiting the Secretion of Human Adrenocortical Hormones.Medical science monitor : international medical journal of experimental and clinical research · 2015Article
- Modeling the responses to resistance training in an animal experiment study.BioMed research international · 2015Article
- A mixed-effects model of the dynamic response of muscle gene transcript expression to endurance exercise.European journal of applied physiology · 2013Article
- Population pharmacodynamic parameter estimation from sparse sampling: effect of sigmoidicity on parameter estimates.The AAPS journal · 2009Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The purpose of this study was to evaluate the effects of population size, number of samples per individual, and level of interindividual variability (IIV) on the accuracy and precision of pharmacodynamic (PD) parameter estimates. Response data were simulated from concentration input data for an inhibitory sigmoid drug efficacy (E(max)) model using Nonlinear Mixed Effect Modeling, version 5 (NONMEM). Seven designs were investigated using different concentration sampling windows ranging from 0 to 3 EC(50) (EC(50) is the drug concentration at 50% of the E(max)) units. The response data were used to estimate the PD and variability parameters in NONMEM. The accuracy and precision of parameter estimates after 100 replications were assessed using the mean and SD of percent prediction error, respectively. Four samples per individual were sufficient to provide accurate and precise estimate of almost all of the PD and variability parameters, with 100 individuals and IIV of 30%. Reduction of sample size resulted in imprecise estimates of the variability parameters; however, the PD parameter estimates were still precise. At 45% IIV, designs with 5 samples per individual behaved better than those designs with 4 samples per individual. For a moderately variable drug with a high Hill coefficient, sampling from the 0.1 to 1, 1 to 2, 2 to 2.5, and 2.5 to 3 EC(50) window is sufficient to estimate the parameters reliably in a PD study.
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