ArticleCPT: pharmacometrics & systems pharmacology2025
Generating Control Groups for Organ Impairment Studies: A Case-Study Comparing Statistical and Population Pharmacokinetic-Based Matching Approaches.
Article in CPT: pharmacometrics & systems pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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.
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.
Who cites it
1 citing paper in PubMed.
- Generating Control Groups for Organ Impairment Studies: A Case-Study Comparing Statistical and Population Pharmacokinetic-Based Matching Approaches.CPT: pharmacometrics & systems pharmacology · 2025Article
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Authors and funding
4 authors.
Funding
Abstract
A common challenge in conducting phase 1 studies that assess the impact of organ impairment on the pharmacokinetics of a drug is the recruitment of a demographically matched control group. The work presented here evaluated alternative approaches for generating control groups in these studies. Available phase 1 data from the upadacitinib and elagolix clinical programs were leveraged as case studies. A statistical matching approach and a population pharmacokinetic model-based approach were evaluated retrospectively for these programs' hepatic and renal impairment clinical studies. Geometric mean ratios of logarithmically transformed C
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Registered trials
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