Virtual Bioequivalence Assessment of Long-acting Injectable Suspensions Using PBPK Modeling: Part 1. Impact of particle Size on Formulation Variability.
Article in The AAPS journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
0numbers the graph read from it
0cells of the map it votes in
1citing 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.
Khondoker AlamDivision of Quantitative Methods and Modeling, Office of Research and Standards/OGD/CDER/FDA, Silver Spring, MD, United States of America.ORCID 0000-0001-8757-2412
Eleftheria TsakalozouDivision of Quantitative Methods and Modeling, Office of Research and Standards/OGD/CDER/FDA, Silver Spring, MD, United States of America.ORCID 0000-0003-1993-8528
Mark DonnellyDivision of Quantitative Methods and Modeling, Office of Research and Standards/OGD/CDER/FDA, Silver Spring, MD, United States of America.ORCID 0000-0001-7537-9615
Kairui FengDivision of Quantitative Methods and Modeling, Office of Research and Standards/OGD/CDER/FDA, Silver Spring, MD, United States of America.ORCID 0009-0007-5206-1920
This study presents a workflow for virtual bioequivalence (VBE) assessment of 3-month paliperidone palmitate (PP) long-acting injectable (LAI) suspensions using a novel physiologically-based pharmacokinetic (PBPK) model. The mechanistic absorption and PBPK model was implemented in the Simcyp® Simulator and calibrated against individual concentration-time profiles derived from a published and validated population pharmacokinetic model. The model was able to accurately simulate drug concentration profiles after PP administration. Across 1000 subjects, four model-predicted bioequivalence (BE) metrics, including C
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.
Virtual Bioequivalence Assessment of Long-acting Injectable Suspensions Using PBPK Modeling: Part 1. Impact of particle Size on Formulation Variability. · full record | OpenQuestion