Evidence map›Paper›PMID 29564719›Full record

ArticlePharmaceutical research2018

Investigation of the Discriminatory Ability of Pharmacokinetic Metrics for the Bioequivalence Assessment of PEGylated Liposomal Doxorubicin.

Li-Feng Hsu

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Article in Pharmaceutical research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.3field-weighted citation impact, top 46% 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

7 citing papers in PubMed, 9 citations in OpenAlex.

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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

1 author at 1 institution in 1 country.

Li-Feng HsuDivision of Pharmaceutical Science, Center for Drug Evaluation (CDE), 3F, No.465, Sec.6, Zhongxiao E. Rd, Taipei, 11557, Taiwan. Lfhsu@cde.org.tw.
Development Center for Biotechnology · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe purpose of the study was to construct a population pharmacokinetic model for pegylated liposomal doxorubicin and use the final model to investigate the discrimination performance of pharmacokinetic metrics (e.g., C

methodsA model was simultaneously built to characterize the concentration time profiles of liposome-encapsulated doxorubicin and free doxorubicin using NONMEM. The different scenarios associated with changes in release rate (Rel) were simulated based on the final parameters. 500 simulated virtual bioequivalence (BE) studies were performed for each scenario, and power curves for the probability of declaring BE were also computed.

resultsThe concentration time profiles of liposome-encapsulated doxorubicin and free doxorubicin were well described by a one- and two-compartment model, respectively. pAUC

conclusionsIn addition to the traditional metrics, partial AUC should be included for the BE assessment of pegylated liposomal doxorubicin.

Indexed as

Models, BiologicalAntibiotics, AntineoplasticArea Under CurveDoxorubicinDrug LiberationFeasibility StudiesPolyethylene GlycolsTherapeutic EquivalencyTime FactorsAntibiotics, AntineoplasticDoxorubicinliposomal doxorubicinPolyethylene Glycolsbioequivalencemodeling and simulationpartial AUCpegylated liposomal doxorubicinpopulation pharmacokinetics

Identifiers

PMID29564719
OpenAlexW2790628064

What OpenQuestion holds

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Registered trials

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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.