Evidence map›Paper›PMID 12968981›Full record

Trial reportBritish journal of clinical pharmacology2003

Population pharmacokinetics of liposomal daunorubicin in children.

Georg Hempel, Dirk Reinhardt, Ursula Creutzig, Joachim Boos

Open access · bronzeAbstract readClinical TrialMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 11% 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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Pharmacokinetic and Pharmacodynamic Properties of Drug Delivery Systems.The Journal of pharmacology and experimental therapeutics · 2019
    Review
  8. Article
  9. Review
  10. Review
  11. Review
  12. 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

4 authors at 2 institutions in 1 country.

Georg HempelInstitut für Pharmazeutische und Medizinische Chemie, Westfälische Wilhelms-Universität, Hittorfstrasse 58-62, 48149 Münster, Germany. hempege@uni-muenster.de
Dirk Reinhardt
Ursula Creutzig
Joachim Boos
Zentrum für Kinderheilkunde · DEUniversity of Münster · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo investigate the population pharmacokinetics of daunorubicin in children after administration of liposomal daunorubicin (Daunoxome).

methodsPlasma samples from 19 children with relapsed acute myeloic leukaemia and five children with other malignancies were collected. Daunoxome was administered as a 1- to 2.5 h infusion with doses ranging from 30 to 60 mg m(-2). Overall, 214 samples were analysed for daunorubicin using capillary electrophoresis, and population pharmacokinetic modelling was performed using NONMEM.

resultsThe data were best described by a one compartment model. Inclusion of interoccasion variability in the model (16.7% for clearance) improved strongly the precision of the estimates. The inclusion of body surface area or height as a covariate decreased interindividual variability. However, the best fit was obtained using the absolute dose, and when weight was included as a covariate for clearance (CL) and volume of distribution (V ). The final parameter estimates were: CL 6.41 ml h(-1) kg(-1) +/- 0.5 51% and V 65.4 ml kg(-1) +/- 0.5 27% (population mean +/- 0.5 interindividual variability). The area under the curve at a dose of 60 mg m(-2) was 231 mg l (-1)h.

conclusionsIn comparison with free daunorubicin, Daunoxome shows a low volume of distribution, a lower clearance and a lower interindividual variability in these parameters. This might be advantageous in reducing the variability in exposure to the drug.

Indexed as

Acute DiseaseAdolescentAdultAntibiotics, AntineoplasticChildChild, PreschoolDaunorubicinDrug CarriersHumansInfantInfusions, IntravenousLeukemia, MyeloidLiposomesNeoplasmsRecurrenceAntibiotics, AntineoplasticDaunorubicinDrug CarriersLiposomes

Identifiers

PMID12968981
PMCPMC1884379
OpenAlexW1560040777

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.