Evidence map›Paper›PMID 24548174›Full record

ArticleBritish journal of clinical pharmacology2015

Methods and software tools for design evaluation in population pharmacokinetics-pharmacodynamics studies.

Joakim Nyberg, Caroline Bazzoli, Kay Ogungbenro, Alexander Aliev, Sergei Leonov, Stephen Duffull, Andrew C Hooker, France Mentré

Abstract readComparative Study
In one paragraph

Article in British journal of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed
–field-weighted citation impact
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

41 citing papers in PubMed.

  1. Trial
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  3. Observational
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  5. Article
  6. Review
  7. Article
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  10. Article
  11. Tutorial for $DESIGN in NONMEM: Clinical trial evaluation and optimization.CPT: pharmacometrics & systems pharmacology · 2021
    Article
  12. Metaheuristics for pharmacometrics.CPT: pharmacometrics & systems pharmacology · 2021
    Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Review
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.

Joakim NybergDepartment of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.
Caroline Bazzoli
Kay Ogungbenro
Alexander Aliev
Sergei Leonov
Stephen Duffull
Andrew C Hooker
France Mentré

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Population pharmacokinetic (PK)-pharmacodynamic (PKPD) models are increasingly used in drug development and in academic research; hence, designing efficient studies is an important task. Following the first theoretical work on optimal design for nonlinear mixed-effects models, this research theme has grown rapidly. There are now several different software tools that implement an evaluation of the Fisher information matrix for population PKPD. We compared and evaluated the following five software tools: PFIM, PkStaMp, PopDes, PopED and POPT. The comparisons were performed using two models, a simple-one compartment warfarin PK model and a more complex PKPD model for pegylated interferon, with data on both concentration and response of viral load of hepatitis C virus. The results of the software were compared in terms of the standard error (SE) values of the parameters predicted from the software and the empirical SE values obtained via replicated clinical trial simulation and estimation. For the warfarin PK model and the pegylated interferon PKPD model, all software gave similar results. Interestingly, it was seen, for all software, that the simpler approximation to the Fisher information matrix, using the block diagonal matrix, provided predicted SE values that were closer to the empirical SE values than when the more complicated approximation was used (the full matrix). For most PKPD models, using any of the available software tools will provide meaningful results, avoiding cumbersome simulation and allowing design optimization.

Indexed as

PharmacokineticsSoftwareDrug DiscoveryHumansModels, BiologicalNonlinear DynamicsFisher information matrixnonlinear mixed effect modelsoptimal designpopulation designpopulation pharmacokinetics-pharmacodynamics

Identifiers

PMID24548174
PMCPMC4294071

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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.