ArticleThe AAPS journal2026
Quantitative Estimation of Clinical Intrasubject Variability of a Pharmacokinetic Parameter.
Article in The AAPS journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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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.
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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.
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Authors and funding
6 authors.
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Abstract
The virtual bioequivalence (VBE) approach, which employs physiologically based pharmacokinetic (PBPK) modeling in lieu of clinical bioequivalence (BE) studies, provides a valuable alternative for the pharmaceutical industry. The VBE has the potential to substantially reduce both the time and costs associated with traditional clinical BE studies. Furthermore, this approach supports ethical principles by eliminating the need to expose healthy volunteers to investigational compounds without medical benefit. Intrasubject variability (intrasubject coefficient of variation, ICV) is a main factor for balanced cross-over design BE studies in calculating the confidence intervals for the geometric mean ratio of AUC and C
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Registered trials
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