Evidence map›Paper›PMID 29737457›Full record

ReviewClinical pharmacokinetics2018

A Physiologically-Based Pharmacokinetic Model to Describe Ciprofloxacin Pharmacokinetics Over the Entire Span of Life.

Jan-Frederik Schlender, Donato Teutonico, Katrin Coboeken, Katrin Schnizler, Thomas Eissing, Stefan Willmann, Ulrich Jaehde, Heino Stass

Open access · hybridAbstract readReview
In one paragraph

Review in Clinical pharmacokinetics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 10% 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

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
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  11. Development and application of a pediatric mechanistic kidney model.CPT: pharmacometrics & systems pharmacology · 2022
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  14. Oral Antibiotics in Patients with Short Bowel Syndrome: Do or Don't?European journal of drug metabolism and pharmacokinetics · 2021
    Article
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  16. Review
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  18. Article
  19. MRGPRX2 and Adverse Drug Reactions.Frontiers in immunology · 2021
    Review
  20. 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 3 institutions in 2 countries.

Jan-Frederik SchlenderInstitute of Pharmacy, Clinical Pharmacy, University of Bonn, Bonn, Germany. jan.schlender@bayer.com.
Donato TeutonicoSystems Pharmacology and Medicine, Bayer AG, 51373, Leverkusen, Germany.
Katrin CoboekenSystems Pharmacology and Medicine, Bayer AG, 51373, Leverkusen, Germany.
Katrin SchnizlerSystems Pharmacology and Medicine, Bayer AG, 51373, Leverkusen, Germany.
Thomas EissingSystems Pharmacology and Medicine, Bayer AG, 51373, Leverkusen, Germany.
Stefan WillmannClinical Pharmacometrics, Bayer AG, Wuppertal, Germany.
Ulrich JaehdeInstitute of Pharmacy, Clinical Pharmacy, University of Bonn, Bonn, Germany.
Heino StassClinical Pharmacology, Bayer AG, Wuppertal, Germany.
Bayer (Germany) · DEUniversity of Bonn · DEServier (France) · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPhysiologically-based pharmacokinetic (PBPK) modeling has received growing interest as a useful tool for the assessment of drug pharmacokinetics by continuous knowledge integration.

objectiveThe objective of this study was to build a ciprofloxacin PBPK model for intravenous and oral dosing based on a comprehensive literature review, and evaluate the predictive performance towards pediatric and geriatric patients.

methodsThe aim of this report was to establish confidence in simulations of the ciprofloxacin PBPK model along the development process to facilitate reliable predictions outside of the tested adult age range towards the extremes of ages. Therefore, mean data of 69 published clinical trials were identified and integrated into the model building, simulation and verification process. The predictive performance on both ends of the age scale was assessed using individual data of 258 subjects observed in own clinical trials.

resultsCiprofloxacin model verification demonstrated no concentration-related bias and accurate simulations for the adult age range, with only 4.8% of the mean observed data points for intravenous administration and 12.1% for oral administration being outside the simulated twofold range. Predictions towards the extremes of ages for the area under the plasma concentration-time curve (AUC) and the maximum plasma concentration (C

conclusionOverall, this ciprofloxacin PBPK modeling approach demonstrated the predictive power of a thoroughly informed middle-out approach towards age groups of interest to potentially support the decision-making process.

Indexed as

Models, BiologicalAdministration, IntravenousAdministration, OralAdolescentAdultAgedAged, 80 and overAge FactorsAnti-Bacterial AgentsArea Under CurveChildChild, PreschoolCiprofloxacinComputer SimulationFemaleHumansAnti-Bacterial AgentsCiprofloxacin

Identifiers

PMID29737457
PMCPMC6267540
OpenAlexW2802817306

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.