ReviewPharmaceutics2020
In Vitro Dissolution and in Silico Modeling Shortcuts in Bioequivalence Testing.
Review in Pharmaceutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 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
8 citing papers in PubMed.
- A Physiologically Based Pharmacokinetic Model to Predict Potential Drug-Drug Interactions of TPN171, a Novel Phosphodiesterase Type 5 Inhibitor.CPT: pharmacometrics & systems pharmacology · 2026Article
- Formulation Strategy of BCS-II Drugs by Coupling Mechanistic In-Vitro and Nonclinical In-Vivo Data with PBPK: Fundamentals of Absorption-Dissolution to Parameterization of Modelling and Simulation.AAPS PharmSciTech · 2025Review
- Research Landscape of Physiologically Based Pharmacokinetic Model Utilization in Different Fields: A Bibliometric Analysis (1999-2023).Pharmaceutical research · 2024Article
- Biopharmaceutics Risk Assessment-Connecting Critical Bioavailability Attributes with In Vitro, In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submissions.The AAPS journal · 2023Review
- Supersaturation and Precipitation Applicated in Drug Delivery Systems: Development Strategies and Evaluation Approaches.Molecules (Basel, Switzerland) · 2023Review
- A Bayesian population physiologically based pharmacokinetic absorption modeling approach to support generic drug development: application to bupropion hydrochloride oral dosage forms.Journal of pharmacokinetics and pharmacodynamics · 2021Article
- Luminal Fluid Motion Inside an In Vitro Dissolution Model of the Human Ascending Colon Assessed Using Magnetic Resonance Imaging.Pharmaceutics · 2021Article
- An In Vitro-In Vivo Simulation Approach for the Prediction of Bioequivalence.Materials (Basel, Switzerland) · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo review in vitro testing and simulation platforms that are in current use to predict in vivo performances of generic products as well as other situations to provide evidence for biowaiver and support drug formulations development.
methodsPubmed and Google Scholar databases were used to review published literature over the past 10 years. The terms used were "simulation AND bioequivalence" and "modeling AND bioequivalence" in the title field of databases, followed by screening, and then reviewing.
resultsA total of 22 research papers were reviewed. Computer simulation using software such as GastroPlus™, PK-Sim
conclusionsComputer simulation platforms need to improve their mechanistic physiologically based pharmacokinetic (PBPK) modeling, and if prospectively validated within a small percentage of error from the observed clinical data, they can be valuable tools in bioequivalence (BE) testing and formulation development.
Indexed as
Identifiers
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.