Evidence map›Paper›PMID 35953664›Full record

ArticleJournal of pharmacokinetics and pharmacodynamics2024

Current practices for QSP model assessment: an IQ consortium survey.

Jason R Chan, Richard Allen, Britton Boras, Antonio Cabal, Valeriu Damian, Francis D Gibbons, Abhishek Gulati, Iraj Hosseini, Jeffrey D Kearns, Ryuta Saito and 7 more

Open access · hybridAbstract read
In one paragraph

Article in Journal of pharmacokinetics and pharmacodynamics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
3.5field-weighted citation impact, top 6% 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Article
  6. Advancing drug development with "Fit-for-Purpose" modeling informed approaches.Journal of pharmacokinetics and pharmacodynamics · 2025
    Review
  7. Review
  8. Review
  9. Editor's note on the themed issue: assessing QSP models and amplifying their impact.Journal of pharmacokinetics and pharmacodynamics · 2024
    Article
  10. An industry perspective on current QSP trends in drug development.Journal of pharmacokinetics and pharmacodynamics · 2024
    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

17 authors at 13 institutions in 3 countries.

Jason R ChanGlobal PKPD and Pharmacometrics, Eli Lilly and Company, Indianapolis, IN, 46285, USA. jrchan@lilly.com.
Richard AllenWorldwide Research, Development and Medical, Pfizer Inc. Kendall Square, Cambridge, MA, 02139, USA.
Britton BorasWorldwide Research, Development and Medical, Pfizer Inc.,, La Jolla, CA, 92121, USA.
Antonio CabalEisai Inc., NJ, Nutley, USA.
Valeriu DamianGlaxoSmithKline, Collegeville, PA, 19426, USA.
Francis D Gibbons, Takeda, Cambridge, MA, 02139, USA.
Abhishek GulatiMerck & Co. Inc., Rahway, NJ, USA.
Iraj HosseiniGenentech Inc., South San Francisco, CA, 94080, USA.
Jeffrey D KearnsNovartis Institutes for BioMedical Research, Cambridge, MA, 02139, USA.
Ryuta SaitoInnovative Research Division, Mitsubishi Tanabe Pharma Corporation, Yokohama, Japan.
Lourdes Cucurull-SanchezGlaxoSmithKline, Stevenage, Hertfordshire, UK.
Jangir SelimkhanovTakeda Development Center Americas Inc., San Diego, CA, 92121, USA.
Andrew M SteinPharmacometrics, Novartis Institutes of BioMedical Research, Cambridge, MA, USA.
Kenichi UmeharaRoche Pharmaceutical Research and Early Development, Basel, Switzerland.
Guanyu WangDrug Metabolism and Pharmacokinetics, Vertex Pharmaceuticals, Abingdon, Oxfordshire, UK.
Weirong WangClinical Pharmacology and Pharmacometrics, Janssen Research and Development, LLC, Spring House, PA, 19477, USA.
Susana Neves-ZaphData and Data Science, Translational Disease Modeling, Sanofi, USA.
Pfizer (United States) · USTakeda (United States) · USEisai (United States) · USEli Lilly (United States) · USGlaxoSmithKline (United Kingdom) · GBGlaxoSmithKline (United States) · USJanssen (United States) · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USMitsubishi Tanabe Pharma CorporationNovartis (United States) · USRoche (Switzerland) · CHSanofi (United States) · USVertex Pharmaceuticals (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Quantitative Systems Pharmacology (QSP) modeling is increasingly applied in the pharmaceutical industry to influence decision making across a wide range of stages from early discovery to clinical development to post-marketing activities. Development of standards for how these models are constructed, assessed, and communicated is of active interest to the modeling community and regulators but is complicated by the wide variability in the structures and intended uses of the underlying models and the diverse expertise of QSP modelers. With this in mind, the IQ Consortium conducted a survey across the pharmaceutical/biotech industry to understand current practices for QSP modeling. This article presents the survey results and provides insights into current practices and methods used by QSP practitioners based on model type and the intended use at various stages of drug development. The survey also highlights key areas for future development including better integration with statistical methods, standardization of approaches towards virtual populations, and increased use of QSP models for late-stage clinical development and regulatory submissions.

Indexed as

Drug DevelopmentDrug IndustryHumansModels, BiologicalNetwork PharmacologySurveys and QuestionnairesDecision MakingDrug IndustryModeling and SimulationNetwork Pharmacology

Identifiers

PMID35953664
PMCPMC9371373
OpenAlexW4291398410

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.