Evidence map›Paper›PMID 37303132›Full record

ArticleCPT: pharmacometrics & systems pharmacology2023

Pharmacokinetic analysis across studies to drive knowledge-integration: A tutorial on individual patient data meta-analysis (IPDMA).

Rob C van Wijk, Marjorie Z Imperial, Radojka M Savic, Belén P Solans

Abstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 5 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

13 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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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.

Rob C van WijkUniversity of California San Francisco Schools of Pharmacy and Medicine, San Francisco, California, USA.ORCID 0000-0001-7247-1360
Marjorie Z ImperialUniversity of California San Francisco Schools of Pharmacy and Medicine, San Francisco, California, USA.
Radojka M SavicUniversity of California San Francisco Schools of Pharmacy and Medicine, San Francisco, California, USA.
Belén P SolansUniversity of California San Francisco Schools of Pharmacy and Medicine, San Francisco, California, USA.ORCID 0000-0003-4621-5480

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Answering challenging questions in drug development sometimes requires pharmacokinetic (PK) data analysis across different studies, for example, to characterize PKs across diverse regions or populations, or to increase statistical power for subpopulations by combining smaller size trials. Given the growing interest in data sharing and advanced computational methods, knowledge integration based on multiple data sources is increasingly applied in the context of model-informed drug discovery and development. A powerful analysis method is the individual patient data meta-analysis (IPDMA), leveraging systematic review of databases and literature, with the most detailed data type of the individual patient, and quantitative modeling of the PK processes, including capturing heterogeneity of variance between studies. The methodology that should be used in IPDMA in the context of population PK analysis is summarized in this tutorial, highlighting areas of special attention compared to standard PK modeling, including hierarchical nested variability terms for interstudy variability, and handling between-assay differences in limits of quantification within a single analysis. This tutorial is intended for any pharmacological modeler who is interested in performing an integrated analysis of PK data across different studies in a systematic and thorough manner, to answer questions that transcend individual primary studies.

Indexed as

Databases, FactualMeta-Analysis as TopicPharmacokineticsDrug DevelopmentHumans

Identifiers

PMID37303132
PMCPMC10508576

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.