NDLI: Evaluation of intravenous midazolam limited sampling models to determine area under the concentration time curve during cytochrome P450 3A baseline, inhibition and induction or activation.

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Evaluation of intravenous midazolam limited sampling models to determine area under the concentration time curve during cytochrome P450 3A baseline, inhibition and induction or activation.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Nguyen, Anh N. Hoffman, Justin T. Tsunoda, Shirley M. Jang, In-Jin Ma, Joseph D.
Description	Country affiliation: United States Author Affiliation: Nguyen AN ( University of California, San Diego, CA, USA.)
Abstract	OBJECTIVE: This study evaluated if previously published limited sampling models (LSMs) accurately predict midazolam area under the concentration time curve (AUC) during cytochrome P450 (CYP) 3A baseline, inhibition and induction/activation. MATERIALS AND METHODS: Plasma midazolam concentrations (n = 108) were obtained where intravenous midazolam was co-administered alone or concomitantly with ketoconazole, itraconazole, aprepitant, rifampin, or pleconaril. Observed AUC was calculated using noncompartmental analysis. Predicted AUC was calculated from the LSMs. Bias and precision were determined by percent mean prediction error (%MPE), percent mean absolute error (%MAE), and percent root mean squared error (%RMSE). RESULTS: Contrasting results were observed for LSMs in predicting CYP3A baseline activity, with the majority of studies resulting in unacceptable bias and precision. During CYP3A inhibition, unacceptable bias and precision were observed from single- and 2-time point LSMs. %MAE and %RMSE values exceeded acceptable limits during CYP3A induction with rifampin. Contrasting results were observed with pleconaril. CONCLUSION: The contrasting results during CYP3A baseline and induction/activation, as well as the unacceptable bias and precision during CYP3A inhibition, limits the widespread use of the previously published LSMs.
File Format	HTM / HTML
ISSN	09461965
Issue Number	7
Volume Number	50
Journal	Int. Journal of Clinical Pharmacology and Therapeutics
Language	English
Publisher	Dustri-Verlag
Publisher Date	2012-07-01
Publisher Place	Germany
Access Restriction	Subscribed
Subject Keyword	Discipline Pharmacology Cytochrome P-450 Cyp3a Inhibitors Midazolam Pharmacology Area Under Curve Cytochrome P-450 Cyp3a Metabolism Enzyme Induction Humans Injections, Intravenous Journal Article
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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