Model‐Based Evaluation of Linear Limited and Bayesian Sparse Sampling for Therapeutic Monitoring of Recombinant Coagulation Factor IX.
Dosing of coagulation factor products is mainly determined based on a patient's body weight; however, several studies have reported high interindividual variability in their pharmacokinetics (PK). The objective of this study was to develop and evaluate 2 sparse sampling methods for the estimation of...
| Publicado en: | Journal of Clinical Pharmacology Vol. 60; no. 11; pp. 1453 - 1461 |
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| Autores principales: | , |
| Formato: | equations & formulas research tables/charts Journal Article |
| Publicado: |
Wiley-Blackwell
Nov2020
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=146319927&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 146319927 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00912700 5WH jtl: Journal of Clinical Pharmacology issn: 00912700 maglogo: Y pubinfo: dt: Nov2020 vid: 60 iid: 11 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 146319927 146319927 146319927 10.1002/jcph.1651 146319927 ppf: 1453 ppct: 8 formats: tig: atl: Model‐Based Evaluation of Linear Limited and Bayesian Sparse Sampling for Therapeutic Monitoring of Recombinant Coagulation Factor IX. aug: au: Tegenge, Million A. Mahmood, Iftekhar affil: Office of Biostatistics & Epidemiology, Center for Biologics Evaluation and Research, US Food & Drug Administration, Silver Spring Maryland,, USA sug: subj: Blood Coagulation Factors Administration and Dosage Blood Coagulation Factors Pharmacokinetics Drug Monitoring Methods Models, Statistical Human Adolescence Adult Blood Specimen Collection Dose-Response Relationship, Drug Adolescent: 13-18 years Adult: 19-44 years ab: Dosing of coagulation factor products is mainly determined based on a patient's body weight; however, several studies have reported high interindividual variability in their pharmacokinetics (PK). The objective of this study was to develop and evaluate 2 sparse sampling methods for the estimation of AUC of recombinant factor IX (BeneFIX) as proof of concept for dose individualization. A population pharmacokinetic model was used to generate the plasma factor IX activity‐versus‐time data. The linear limited sampling model (LLSM) was developed based on the correlation of factor IX activity versus AUC0‐72 hours following screening of several blood sampling times in adolescent and adult subjects (n = 90 subjects). Factor IX trough concentrations were predicted from a relationship established from AUC versus factor IX activity measured 72 hours postdosing. Using the best selected sampling time, the LLSM and Bayesian model were validated in separate data sets (n = 75 subjects). Using the LLSM and Bayesian analysis, a blood sample at 24 hours predicted AUC with bias and root mean square error < 5% and < 15%, respectively. The predicted trough concentrations were ≥1 IU/dL in 99% and 100% of subjects by the LLSM and Bayesian model, respectively. The average factor IX dose for a target AUC of 800 IU·h/dL was 61, 60, and 63 IU/kg using the extensive (reference), LLSM and Bayesian model, respectively. Overall, the AUC, trough concentrations and individualized dosing of recombinant factor IX could be reasonably predicted using the LLSM and Bayesian model. pubtype: Academic Journal doctype: equations & formulas research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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