ArticleFrontiers in pharmacology2024
A Bayesian framework for virtual comparative trials and bioequivalence assessments.
Article in Frontiers in pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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.
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.
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Who cites it
6 citing papers in PubMed.
- Accelerating Generic Long-Acting Antiretrovirals for Global HIV Treatment: Workshop Findings and a Roadmap to Access.Clinical pharmacology and therapeutics · 2026Article
- Model-Integrated Bioequivalence (MIBE) in Generic Drug Research: Can We Ease the Bioequivalence Burden?Pharmaceutics · 2026Review
- Virtual Bioequivalence Assessment of Long-Acting Injectable Suspensions Using PBPK Modeling: Part 2. Type I Error and Safe Space Analyses.The AAPS journal · 2026Article
- Virtual Bioequivalence Assessment of Long-acting Injectable Suspensions Using PBPK Modeling: Part 1. Impact of particle Size on Formulation Variability.The AAPS journal · 2026Article
- Evaluating Model-Based Extrapolation of Plasma Exposure for Long-Acting Injectable Products: From Single- to Multiple-Dose Trials.CPT: pharmacometrics & systems pharmacology · 2026Article
- Using the Simcyp R Package for PBPK Simulation Workflows With the Simcyp Simulator.CPT: pharmacometrics & systems pharmacology · 2025Article
Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Introduction: In virtual bioequivalence (VBE) assessments, pharmacokinetic models informed with Methods: We illustrate our approach with a case study on a hypothetical paliperidone palmitate (PP) generic long-acting injectable suspension formulation using a validated population pharmacokinetic model published for the reference formulation. BE testing, study power, type I and type II error analyses or their Bayesian equivalents, and safe-space analyses are demonstrated. Results: The fully Bayesian workflow is more precise than the frequentist workflow. Decisions about bioequivalence and safe space analyses in the two workflows can differ markedly because the Bayesian analyses are more accurate. Discussion: A Bayesian framework can adequately control consumer risk and minimize producer risk . It rewards data gathering and model integration to make the best use of prior information. The frequentist approach is less precise but faster to compute, and it can still be used as a first step to narrow down the parameter space to explore in safe-space analyses.
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Registered trials
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 Socratic graph.