Evidence map›Paper›PMID 31161268›Full record

ReviewThe AAPS journal2019

Translational Quantitative Systems Pharmacology in Drug Development: from Current Landscape to Good Practices.

Jane P F Bai, Justin C Earp, Venkateswaran C Pillai

Abstract readReview
PubMed Publisher
In one paragraph

Review in The AAPS journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
6.0field-weighted citation impact, top 3% 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

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 49 citations in OpenAlex.

  1. In Silico Clinical Trials in Drug Development: A Systematic Review.Therapeutic innovation & regulatory science · 2026
    Pooled it
  2. Review
  3. Review
  4. Article
  5. Article
  6. Review
  7. Review
  8. Future Directions for Quantitative Systems Pharmacology.Handbook of experimental pharmacology · 2025
    Review
  9. Review
  10. In Silico Clinical Trials: Is It Possible?Methods in molecular biology (Clifton, N.J.) · 2024
    Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. Article
  16. Evaluation framework for systems models.CPT: pharmacometrics & systems pharmacology · 2022
    Article
  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

3 authors at 1 institution in 1 country.

Jane P F BaiOffice of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20903, USA. Jane.bai@fda.hhs.gov.
Justin C EarpOffice of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20903, USA.
Venkateswaran C PillaiOffice of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20903, USA.
Center for Drug Evaluation and Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Systems pharmacology approaches have the capability of quantitatively linking the key biological molecules relevant to a drug candidate's mechanism of action (drug-induced signaling pathways) to the clinical biomarkers associated with the proposed target disease, thereby quantitatively facilitating its development and life cycle management. In this review, the model attributes of published quantitative systems pharmacology (QSP) modeling for lowering cholesterol, treating salt-sensitive hypertension, and treating rare diseases as well as describing bone homeostasis and related pharmacological effects are critically reviewed with respect to model quality, calibration, validation, and performance. We further reviewed the common practices in optimizing QSP modeling and prediction. Notably, leveraging genetics and genomic studies for model calibration and validation is common. Statistical and quantitative assessment of QSP prediction and handling of model uncertainty are, however, mostly lacking as are the quantitative and statistical criteria for assessing QSP predictions and the covariance matrix of coefficients between the parameters in a validated virtual population. To accelerate advances and application of QSP with consistent quality, a list of key questions is proposed to be addressed when assessing the quality of a QSP model in hopes of stimulating the scientific community to set common expectations. The common expectations as to what constitutes the best QSP modeling practices, which the scientific community supports, will advance QSP modeling in the realm of informed drug development. In the long run, good practices will extend the life cycles of QSP models beyond the life cycles of individual drugs.

Indexed as

Models, BiologicalDrug DevelopmentDrugs, InvestigationalHumansPharmacologySystems BiologyTranslational Research, BiomedicalDrugs, Investigationalbest practicesbiomarkerslife cycle of QSP modelsmodel assessmentvirtual patients

Identifiers

PMID31161268
OpenAlexW2948323141

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.