2013
DOI: 10.18433/j3hs42
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Novel Population Pharmacokinetic Method Compared to the Standard Noncompartmental Approach to Assess Bioequivalence of Iron Gluconate Formulations

Abstract: -Purpose: Iron-containing products are atypical in terms of their pharmacokinetic properties because iron is only removed by plasma sampling and is non-linear. This study aims to present a novel way of assessing the relative bioavailability of two sodium ferric gluconate complex (SFGC) formulations and compare this approach to a standard previously published noncompartmental approach. Methods: Data were from openlabel, randomized, single-dose studies (Study 1 was parallel whereas Study 2 was crossover). Subjec… Show more

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Cited by 2 publications
(2 citation statements)
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References 35 publications
(31 reference statements)
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“…63,64 Besides the previously described examples related to alendronate (fitting the urinary excreted amounts), corticosteroids (using the skin blanching study guidance), and albuterol (using FEV 1 and the dose scale approach), we have also proposed the use of the population approach for other specific cases (topical acyclovir, cyclosporine, and iron gluconate), which will not be described further as their methodology and results have been described extensively elsewhere. [65][66][67] In the studies involving cyclosporine and iron gluconate, a direct comparison was made between results obtained by the compartmental and NCPT methods, and the conclusions that were reached by both approaches were similar.…”
Section: Our Experiences With Model-based Bioequivalence Assessmentsmentioning
confidence: 99%
See 1 more Smart Citation
“…63,64 Besides the previously described examples related to alendronate (fitting the urinary excreted amounts), corticosteroids (using the skin blanching study guidance), and albuterol (using FEV 1 and the dose scale approach), we have also proposed the use of the population approach for other specific cases (topical acyclovir, cyclosporine, and iron gluconate), which will not be described further as their methodology and results have been described extensively elsewhere. [65][66][67] In the studies involving cyclosporine and iron gluconate, a direct comparison was made between results obtained by the compartmental and NCPT methods, and the conclusions that were reached by both approaches were similar.…”
Section: Our Experiences With Model-based Bioequivalence Assessmentsmentioning
confidence: 99%
“…Model directly incorporates and addresses characteristics that are not related to the formulation performances allowing a more robust assessment of BE. In the case of iron products, this approach seems to require a much lower sample size compared to NCPT analysis 67…”
Section: How To Assess Bioequivalence Using Model-based Approaches?mentioning
confidence: 99%