ArticleBritish journal of clinical pharmacology2008
Development of a sufficient design for estimation of fluconazole pharmacokinetics in people with HIV infection.
Article in British journal of clinical pharmacology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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Who cites it
12 citing papers in PubMed, 19 citations in OpenAlex.
- Optimizing Clinical Study Designs for CAR-T Cell Therapy: Development of an Efficient Sampling Strategy Through Optimal Experimental Design.CPT: pharmacometrics & systems pharmacology · 2026Article
- A Pharmacokinetic Analysis of Intravenous Fluconazole in Adult Patients Undergoing Mechanical Circulatory Support Device Implantation.Clinical pharmacokinetics · 2026Article
- Optimizing fluconazole dosing in acute renal failure patients undergoing continuous renal replacement therapy: A population pharmacokinetic/pharmacodynamic study.Frontiers in pharmacology · 2025Article
- A Physiological-Based Pharmacokinetic Model Embedded with a Target-Mediated Drug Disposition Mechanism Can Characterize Single-Dose Warfarin Pharmacokinetic Profiles in Subjects with VariousDrug metabolism and disposition: the biological fate of chemicals · 2023Article
- Suboptimal Dosing of Fluconazole in Critically Ill Patients: Time To Rethink Dosing.Antimicrobial agents and chemotherapy · 2020Observational
- Target attainment analysis and optimal sampling designs for population pharmacokinetic study on piperacillin/tazobactam in neonates and young infants.European journal of clinical pharmacology · 2016Article
- First dose in neonates: are juvenile mice, adults and in vitro-in silico data predictive of neonatal pharmacokinetics of fluconazole.Clinical pharmacokinetics · 2014Article
- Population pharmacokinetics of metformin in healthy subjects and patients with type 2 diabetes mellitus: simulation of doses according to renal function.Clinical pharmacokinetics · 2013Article
- Population pharmacokinetics of fluconazole in critically ill patients receiving continuous venovenous hemodiafiltration: using Monte Carlo simulations to predict doses for specified pharmacodynamic targets.Antimicrobial agents and chemotherapy · 2011Article
- Optimal designs for population pharmacokinetic studies of oral artesunate in patients with uncomplicated falciparum malaria.Malaria journal · 2011Article
- Interpreting population pharmacokinetic-pharmacodynamic analyses - a clinical viewpoint.British journal of clinical pharmacology · 2011Review
- Towards optimal design of anti-malarial pharmacokinetic studies.Malaria journal · 2009Article
Corrections and comments
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Authors and funding
5 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo assess an optimal design that is sufficient to gain precise estimates of the pharmacokinetic (PK) parameters for fluconazole in people with HIV infection.
methodsTwo studies were identified, the first in healthy volunteers and the second in HIV patients. The investigators (J.F.R. and S.B.D.) were blinded to the second study results. The healthy volunteer study was modelled and a design was found to estimate the PK parameters. The design was evaluated by comparison of the standard errors of the parameters and the predictive performance of the optimal design. The predictive performance was assessed by comparing model predictions against observed concentrations for two models. The first model, termed 'sufficient design', was developed from data extracted from the HIV study that corresponded to the optimal design. The second model, termed 'HIV outcome model', by modelling all the data from the HIV study.
resultsAn optimal design HIV study was developed which had considerably fewer blood samples and dosing arms compared with the actual HIV study. The optimized design performed as well as the actual HIV study in terms of parameter precision. The performance of the design, described as the precision (mg l(-1))(2) (95% confidence interval) of the predicted concentrations to the actual concentrations for the 'sufficient design' and 'HIV outcome model' models were: 0.63 (0.40, 0.87) and 0.56 (0.32, 0.79), respectively.
conclusionThis study demonstrates how data from healthy volunteers can be utilized via optimal design methodology to design a successful study in the target population.
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