Evidence map›Paper›PMID 37386340›Full record

ReviewJournal of pharmacokinetics and pharmacodynamics2024

Assessing the performance of QSP models: biology as the driver for validation.

Fulya Akpinar Singh, Nasrin Afzal, Shepard J Smithline, Craig J Thalhauser

Abstract readReview
In one paragraph

Review 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 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. New approach methodologies (NAMs) for preclinical and translational evaluation of mRNA-lipid nanoparticle (LNP) therapeutics.Journal of controlled release : official journal of the Controlled Release Society · 2026
    Review
  4. Review
  5. Article
  6. Article
  7. Review
  8. Editor's note on the themed issue: assessing QSP models and amplifying their impact.Journal of pharmacokinetics and pharmacodynamics · 2024
    Article
  9. 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

4 authors.

Fulya Akpinar SinghGenmab US, Inc., 777 Scudders Mill Rd Bldg 2 4th Floor, Plainsboro, NJ, 08536, USA.
Nasrin AfzalGenmab US, Inc., 777 Scudders Mill Rd Bldg 2 4th Floor, Plainsboro, NJ, 08536, USA.
Shepard J SmithlineGenmab US, Inc., 777 Scudders Mill Rd Bldg 2 4th Floor, Plainsboro, NJ, 08536, USA.
Craig J ThalhauserGenmab US, Inc., 777 Scudders Mill Rd Bldg 2 4th Floor, Plainsboro, NJ, 08536, USA. crth@genmab.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Validation of a quantitative model is a critical step in establishing confidence in the model's suitability for whatever analysis it was designed. While processes for validation are well-established in the statistical sciences, the field of quantitative systems pharmacology (QSP) has taken a more piecemeal approach to defining and demonstrating validation. Although classical statistical methods can be used in a QSP context, proper validation of a mechanistic systems model requires a more nuanced approach to what precisely is being validated, and what role said validation plays in the larger context of the analysis. In this review, we summarize current thoughts of QSP validation in the scientific community, contrast the aims of statistical validation from several contexts (including inference, pharmacometrics analysis, and machine learning) with the challenges faced in QSP analysis, and use examples from published QSP models to define different stages or levels of validation, any of which may be sufficient depending on the context at hand.

Indexed as

Models, BiologicalAnimalsHumansMachine LearningReproducibility of ResultsSystems BiologyValidation Studies as TopicModel assessmentModel calibrationModel validationQuantitative systems pharmacology

Identifiers

PMID37386340
PMCPMC11576624

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.