Trial reportThe AAPS journal2019
Development of In Vitro-In Vivo Correlation for Upadacitinib Extended-Release Tablet Formulation.
Trial report in The AAPS journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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
16 citing papers in PubMed, 38 citations in OpenAlex.
- Chromatographic Characterization of Nasal and Inhalation Drug Products: A Review of Liquid Chromatography Strategies for Formulation Assessment, Particle Size Correlation, and In Vitro Performance Testing.Biomedical chromatography : BMC · 2026Review
- Disruption of metabolic licensing by JAK inhibitors constrains CD8 T cell activation and effector function.Cell death & disease · 2026Article
- Upadacitinib as rescue therapy for acute severe ulcerative colitis and severe Crohn's disease - current knowledge and future directions.Pharmacological reports : PR · 2026Review
- Managing Acute Severe Ulcerative Colitis in 2025 and Beyond.Current gastroenterology reports · 2026Review
- Disruption of metabolic licensing by JAK inhibitors constrains CD8 T cell activation and effector function.Research square · 2025Article
- Patients with Crohn's Disease and Ileostomy Can Respond to Upadacitinib.Digestive diseases and sciences · 2025Article
- Model-Informed Paradigm in Drug Development-An End-To-End Case Study From Upadacitinib Development.Clinical and translational science · 2025Review
- Real-world effectiveness of upadacitinib in Crohn's disease: a UK multicentre retrospective cohort study.Frontline gastroenterology · 2024Article
- Predicting ADMET Properties from Molecule SMILE: A Bottom-Up Approach Using Attention-Based Graph Neural Networks.Pharmaceutics · 2024Article
- Effectiveness of Upadacitinib for Patients With Acute Severe Ulcerative Colitis: A Multicenter Experience.The American journal of gastroenterology · 2024Article
- Integrating Nanotechnological Advancements of Disease-Modifying Anti-Rheumatic Drugs into Rheumatoid Arthritis Management.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary.The AAPS journal · 2023Article
- Utility of Modeling and Simulation Approach to Support the Clinical Relevance of Dissolution Specifications: a Case Study from Upadacitinib Development.The AAPS journal · 2022Article
- α-Mangostin Nanoparticles Cytotoxicity and Cell Death Modalities in Breast Cancer Cell Lines.Molecules (Basel, Switzerland) · 2021Review
- Review
- Clinical Pharmacokinetics of Upadacitinib: Review of Data Relevant to the Rheumatoid Arthritis Indication.Clinical pharmacokinetics · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Upadacitinib is a selective Janus Kinase 1 inhibitor which is being developed for the treatment of several inflammatory diseases including rheumatoid arthritis. Upadacitinib was evaluated in Phase 3 studies as an oral extended-release (ER) formulation administered once daily. The purpose of this study was to develop a level A in vitro-in vivo correlation (IVIVC) for upadacitinib ER formulation. The pharmacokinetics of four upadacitinib extended-release formulations with different in vitro release characteristics and an immediate-release capsule formulation of upadacitinib were evaluated in 20 healthy subjects in a single-dose, randomized, crossover study. In vivo pharmacokinetic data and in vitro dissolution data (USP Dissolution Apparatus 1; pH 6.8; 100 rpm) were used to establish a level A IVIVC. Three formulations were used to establish the IVIVC, and the fourth formulation was used for external validation. A non-linear IVIVC best described the relationship between upadacitinib in vitro dissolution and in vivo absorption profiles. The absolute percent prediction errors (%PE) for upadacitinib C
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What OpenQuestion holds
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 OpenQuestion graph.