Evidence map›Paper›PMID 17713971›Full record

ReviewClinical pharmacokinetics2007

Integrated pharmacokinetics and pharmacodynamics in drug development.

Jasper Dingemanse, Silke Appel-Dingemanse

Abstract readReview
PubMed Publisher
In one paragraph

Review in Clinical pharmacokinetics, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing 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

20 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Article
  6. CPMKG: a condition-based knowledge graph for precision medicine.Database : the journal of biological databases and curation · 2024
    Article
  7. Frontiers in veterinary science · 2024
    Article
  8. Review
  9. Review
  10. Review
  11. Review
  12. Microtechnology-Based Multi-Organ Models.Bioengineering (Basel, Switzerland) · 2017
    Review
  13. Article
  14. Article
  15. Challenges in design and characterization of ligand-targeted drug delivery systems.Journal of controlled release : official journal of the Controlled Release Society · 2012
    Review
  16. Review
  17. Review
  18. Pharmacokinetic screening of soluble epoxide hydrolase inhibitors in dogs.European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences · 2010
    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.

Jasper DingemanseClinical Pharmacology, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland. jasper.dingemanse@actelion.com
Silke Appel-Dingemanse

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Drug development is a complex, lengthy and expensive process. Pharmaceutical companies and regulatory authorities have recognised that the drug development process needs optimisation for efficiency in view of the return on investments. Pharmacokinetics and pharmacodynamics are the two main principles determining the relationship between dose and response. This article provides an update on integrated approaches towards drug development by linking pharmacokinetics, pharmacodynamics and disease aspects into mathematical models. Gradually, a transition is taking place from a rather empirical approach towards a modelling- and simulation-based approach to drug development. The main learning phases should be phases 0, I and II, whereas phase III studies should merely have a confirmatory purpose. In model-based drug development, mechanism-based mathematical models, which are iteratively refined along the path of development, incorporate the accumulating knowledge of the investigational drug, the disease and their mutual interference in different subsets of the target population. These models facilitate the design of the next study and improve the probability of achieving the projected efficacy and safety endpoints. In this article, several theoretical and practical aspects of an integrated approach towards drug development are discussed, together with some case studies from different therapeutic areas illustrating the application of pharmacokinetic/pharmacodynamic disease models at different stages of drug development.

Indexed as

Drug DesignPharmacokineticsClinical Trials as TopicDrug Delivery SystemsDrug IndustryHumansModels, BiologicalPharmaceutical PreparationsPharmacology, ClinicalPharmaceutical Preparations

Identifiers

What OpenQuestion holds

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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.