Evidence map›Paper›PMID 34651201›Full record

ArticleEuropean journal of clinical pharmacology2022

In silico evaluation of limited sampling strategies for individualized dosing of extended half-life factor IX concentrates in hemophilia B patients.

T Preijers, M W F van Spengler, K Meijer, K Fijnvandraat, K Fischer, F W G Leebeek, M H Cnossen, R A A Mathôt

Open access · hybridAbstract read
In one paragraph

Article in European journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 42% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Limited Sampling Strategies to Estimate the Exposition of Different Lipid Nanocaspules.European journal of drug metabolism and pharmacokinetics · 2026
    Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 1 country.

T PreijersHospital Pharmacy-Clinical Pharmacology, Amsterdam University Medical Center, Amsterdam, The Netherlands.ORCID http://orcid.org/0000-0001-6953-0358
M W F van SpenglerHospital Pharmacy-Clinical Pharmacology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
K MeijerDepartment of Pediatric Hematology, Academic Medical Center Amsterdam, Amsterdam, The Netherlands.
K FijnvandraatDepartment of Hematology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
K FischerVan Creveldkliniek University Medical Center Utrecht, Utrecht, The Netherlands.
F W G LeebeekDepartment of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands.
M H CnossenDepartment of Pediatric Hematology, Erasmus University Medical Center, Sophia Children's Hospital, Rotterdam, The Netherlands.
R A A MathôtHospital Pharmacy-Clinical Pharmacology, Amsterdam University Medical Center, Amsterdam, The Netherlands. r.mathot@amsterdamumc.nl.
Erasmus MC · NLAmsterdam UMC Location University of Amsterdam · NLAmsterdam University Medical Centers · NLUniversity Medical Center Groningen · NLUniversity Medical Center Utrecht · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeHemophilia B is a bleeding disorder, caused by a factor IX (FIX) deficiency. Recently, FIX concentrates with extended half-life (EHL) have become available. Prophylactic dosing of EHL-FIX concentrates can be optimized by assessment of individual pharmacokinetic (PK) parameters. To determine these parameters, limited sampling strategies (LSSs) may be applied. The study aims to establish adequate LSSs for estimating individual PK parameters of EHL-FIX concentrates using in silico evaluation.

methodsMonte Carlo simulations were performed to obtain FIX activity versus time profiles using published population PK models for N9-GP (Refixia), rFIXFc (Alprolix), and rIX-FP (Idelvion). Fourteen LSSs, containing three or four samples taken within 8 days after administration, were formulated. Bayesian analysis was applied to obtain estimates for clearance (CL), half-life (t

resultsFor all PK parameters of N9-GP, rFIXFc and rIX-FP bias was generally acceptable (range: -5% to 5%). For N9-GP, precision of all parameters for all LSSs was acceptable (< 25%). For rFIXFc, precision was acceptable for CL and Time

conclusionBest performing LSSs were LSS with samples taken at days 1, 5, 7, and 8 (N9-GP and rFIXFc) and at days 1, 4, 6, and 8 (rIX-FP), respectively.

Indexed as

Blood Coagulation FactorsBody WeightDelayed-Action PreparationsDose-Response Relationship, DrugDrug Administration ScheduleDrug MonitoringFactor IXHalf-LifeHemophilia BHumansImmunoglobulin Fc FragmentsMetabolic Clearance RateModels, BiologicalMonte Carlo MethodRecombinant Fusion ProteinsSerum Albuminalbutrepenonacog alfaBlood Coagulation FactorsDelayed-Action PreparationsFactor IXfactor IX Fc fusion proteinImmunoglobulin Fc Fragmentsprothrombin complex concentratesRecombinant Fusion ProteinsSerum AlbuminCoagulation factor concentratesCoagulation factor IXComputer simulationHemophilia BPharmacokinetics

Identifiers

PMID34651201
PMCPMC8748341
OpenAlexW3205476785

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.