Evidence map›Paper›PMID 40574578›Full record

ArticleClinical pharmacology and therapeutics2025

Comparison of Regression and Categorical Analysis for Pharmacokinetic Data From Renal Impairment Studies.

Gerald Chun-To So, Ying Grace Li, Stephen D Hall, Jenny Chien, Christopher D Payne, Maria M Posada, Maria Lucia Buziqui Piruzeli, Yan Jin

Abstract readComparative Study
In one paragraph

Article in Clinical pharmacology and therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. Review
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

8 authors.

Gerald Chun-To SoEli Lilly and Company, Indianapolis, Indiana, USA.ORCID 0000-0003-2101-5116
Ying Grace LiEli Lilly and Company, Indianapolis, Indiana, USA.
Stephen D HallEli Lilly and Company, Indianapolis, Indiana, USA.
Jenny ChienEli Lilly and Company, Indianapolis, Indiana, USA.ORCID 0000-0001-9303-5947
Christopher D PayneEli Lilly and Company, Indianapolis, Indiana, USA.ORCID 0000-0003-0549-5455
Maria M PosadaEli Lilly and Company, Indianapolis, Indiana, USA.ORCID 0000-0003-4645-0763
Maria Lucia Buziqui PiruzeliEli Lilly and Company, Indianapolis, Indiana, USA.
Yan JinEli Lilly and Company, Indianapolis, Indiana, USA.ORCID 0000-0001-7547-1841

Funding

Indiana University Comprehensive Training in Clinical PharmacologyT32GM008425 · NIGMS · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI Zeruesenay Desta, Michael Thomas Eadon · 1992 to 2026
$7.7M
Eli Lilly and CompanyNIGMS NIH HHS T32 GM008425NIGMS NIH HHS T32GM008425NIH HHS
6 · The paper itself

Abstract

The US Food and Drug Administration 2024 guidance prefers regression analysis over categorical analysis for pharmacokinetic data for studies that assess pharmacokinetics in patients with impaired renal functions. The objective of this study was to compare these two statistical methods for pharmacokinetic data analysis of renal impairment studies. Baseline data from seven renal impairment studies were pooled to estimate the impact of three creatinine-based equations (Cockcroft-Gault, CKD-EPI

Indexed as

PharmacokineticsRenal InsufficiencyAdultAgedCreatinineFemaleGlomerular Filtration RateHumansMaleMiddle AgedRegression AnalysisRetrospective StudiesUnited StatesCreatinine

Identifiers

PMID40574578
PMCPMC12439002

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.