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Population Pharmacokinetics of Plasma-Derived Factor IX: Procedures for Dose Individualization
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences.
Skane Univ Hosp, Clin Coagulat Res Unit, Malmo, Sweden.
Skane Univ Hosp, Clin Coagulat Res Unit, Malmo, Sweden.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences. (Farmakometri)
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2016 (English)In: Journal of Thrombosis and Haemostasis, ISSN 1538-7933, E-ISSN 1538-7836, Vol. 14, no 4, 724-732 p.Article in journal (Refereed) Published
Abstract [en]

Background: Population pharmacokinetic (POPPK) models describing factor IX (FIX) activity levels in plasma, in combination with individual FIX measurements, may be used to individualize dosing in the treatment of hemophilia B. Objectives: The aim was to reevaluate a previously developed POPPK model for FIX activity and to explore the number and timing of FIX samples required in pharmacokinetic (PK) dose individualization. Methods: The POPPK model was reevaluated using an extended data set. Several sampling schedules, varying with respect to the timing and number of samples, were evaluated in a simulation study with relative dose errors compared between schedules. The performance of individually calculated doses was compared with commonly prescribed FIX doses with respect to the number of patients with a trough FIX activity > 0.01 U mL(-1). Results and conclusions: A three-compartment PK model best described the FIX activity levels. The number and timing of samples greatly influenced imprecision in dose prediction. Schedules with single samples taken on both day 2 and day 3 were identified as being convenient schedules with an acceptable performance level. Individually calculated doses performed better with respect to patient target attainment than a fixed 40 U kg(-1) dose regardless of how many samples were available to calculate individual doses. The results of this study suggest that PK dose tailoring with limited sampling may be applicable for plasma-derived FIX products.

Place, publisher, year, edition, pages
2016. Vol. 14, no 4, 724-732 p.
Keyword [en]
Bayesian forecast; coagulation factor IX; hemophilia; patient-specific modeling; pharmacokinetics
National Category
Hematology
Research subject
Pharmacokinetics and Drug Therapy
Identifiers
URN: urn:nbn:se:uu:diva-278160DOI: 10.1111/jth.13271ISI: 000374979000012PubMedID: 26806557OAI: oai:DiVA.org:uu-278160DiVA: diva2:906173
Available from: 2016-02-23 Created: 2016-02-23 Last updated: 2017-11-30Bibliographically approved

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Brekkan, AriNielsen, Elisabet IJönsson, Siv

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