Evidence map›Paper›PMID 27567102›Full record

ReviewBritish journal of clinical pharmacology2017

Understanding and applying pharmacometric modelling and simulation in clinical practice and research.

Joseph F Standing

Abstract readReview
In one paragraph

Review in British journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 2 pooled it
–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

50 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Observational
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Stochastic pharmacodynamics of a heterogeneous tumour-cell population.Journal of pharmacokinetics and pharmacodynamics · 2025
    Article
  14. Article
  15. Article
  16. Article
  17. Training the next generation of pharmacometric modelers: a multisector perspective.Journal of pharmacokinetics and pharmacodynamics · 2024
    Article
  18. In Silico Clinical Trials: Is It Possible?Methods in molecular biology (Clifton, N.J.) · 2024
    Article
  19. 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

1 author.

Joseph F StandingInfection, Immunity, Inflammation Section, UCL Institute of Child Health, 30 Guilford Street, London, WC1N 1EH.

Funding

Medical Research Council G1002305Medical Research Council MR/M008665/1
6 · The paper itself

Abstract

Understanding the dose-concentration-effect relationship is a fundamental component of clinical pharmacology. Interpreting data arising from observations of this relationship requires the use of mathematical models; i.e. pharmacokinetic (PK) models to describe the relationship between dose and concentration and pharmacodynamic (PD) models describing the relationship between concentration and effect. Drug development requires several iterations of pharmacometric model-informed learning and confirming. This includes modelling to understand the dose-response in preclinical studies, deriving a safe dose for first-in-man, and the overall analysis of Phase I/II data to optimise the dose for safety and efficacy in Phase III pivotal trials. However, drug development is not the boundary at which PKPD understanding and application stops. PKPD concepts will be useful to anyone involved in the prescribing and administration of medicines for purposes such as determining off-label dosing in special populations, individualising dosing based on a measured biomarker (personalised medicine) and in determining whether lack of efficacy or unexpected toxicity maybe solved by adjusting the dose rather than the drug. In clinical investigator-led study design, PKPD can be used to ensure the optimal dose is used, and crucially to define the expected effect size, thereby ensuring power calculations are based on sound prior information. In the clinical setting the most likely people to hold sufficient expertise to advise on PKPD matters will be the pharmacists and clinical pharmacologists. This paper reviews fundamental PKPD principles and provides some real-world examples of PKPD use in clinical practice and applied clinical research.

Indexed as

Computer SimulationModels, BiologicalBiomarkersDose-Response Relationship, DrugDrug DesignHumansPharmaceutical PreparationsPrecision MedicineResearch DesignBiomarkersPharmaceutical Preparationspharmacodynamicspharmacokinetic-pharmacodynamic modellingpharmacokinetics

Identifiers

PMID27567102
PMCPMC5237699

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.