Evidence map›Paper›PMID 24527997›Full record

ReviewBritish journal of clinical pharmacology2015

Model-based clinical drug development in the past, present and future: a commentary.

Holly Kimko, José Pinheiro

Open access · bronzeAbstract readReview
In one paragraph

Review 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 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed
2.9field-weighted citation impact, top 9% 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

29 citing papers in PubMed, 57 citations in OpenAlex.

  1. Article
  2. Scoping review of the role of pharmacometrics in model-informed drug development.Journal of pharmacokinetics and pharmacodynamics · 2025
    Article
  3. Review
  4. Model-informed drug discovery and development approaches to inform clinical trial design and regulatory decisions: A primer for the MENA region.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2024
    Review
  5. Article
  6. Advancing Subcutaneous Dosing Regimens for Biotherapeutics: Clinical Strategies for Expedited Market Access.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024
    Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Supporting Drug Development for Neglected Tropical Diseases Using Mathematical Modeling.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Article
  12. VCPT: pharmacometrics & systems pharmacology · 2021
    Article
  13. Article
  14. Article
  15. Review
  16. Review
  17. Article
  18. Article
  19. Article
  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

2 authors at 2 institutions in 1 country.

Holly KimkoModel Based Drug Development, Janssen Research & Development, LLC of Johnson & Johnson, Raritan, NJ, 08869, USA.
José Pinheiro
Janssen (United States) · USJohnson & Johnson (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Clinical drug development remains a mostly empirical, costly enterprise, in which decision-making is often based on qualitative assessment of risk, without properly leveraging all the relevant data collected throughout the development programme. Model-based drug development (MBDD) has been proposed by regulatory agencies, academia and pharmaceutical companies as a paradigm to modernize drug research through the quantification of risk and combination of information from different sources across time. We present here a historical account of the use of MBDD in clinical drug development, the current challenges and further opportunities for its application in the pharmaceutical industry.

Indexed as

Computer SimulationModels, BiologicalDrug DiscoveryDrug IndustryHumansclinical trial simulationmodel-based drug developmentmodellingPK/PDsimulation

Identifiers

PMID24527997
PMCPMC4294081
OpenAlexW1551451047

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.