ArticleAAPS PharmSciTech2013
In vitro-in vivo correlation of efavirenz tablets using GastroPlus®.
Article in AAPS PharmSciTech, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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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
20 citing papers in PubMed.
- Exploration of IVIVC Deconvolution Methods in a PBPK Platform: Case Example with Tofacitinib.The AAPS journal · 2026Trial
- Population Pharmacokinetic Modeling To Estimate the Contributions of Genetic and Nongenetic Factors to Efavirenz Disposition.Antimicrobial agents and chemotherapy · 2017Trial
- Guiding a Diclofenac Sodium Dual-Release Sustained Formulation Development Through In Vitro-In Vivo Relationship Based on Physiologically Based Pharmacokinetics.Pharmaceutics · 2026Article
- Evaluating the Impact of Intestinal Bile Salts on Drug Absorption Using PBPK Modeling: Case Studies With Efavirenz, Cinnarizine, and Posaconazole.CPT: pharmacometrics & systems pharmacology · 2026Article
- Physiologically Based Pharmacokinetic Modeling of Efavirenz Nanoparticles: from Animal Model to Human Extrapolation.ACS omega · 2025Article
- From In Vivo Predictive Dissolution to Virtual Bioequivalence: A GastroPlusPharmaceuticals (Basel, Switzerland) · 2025Article
- In Vitro-In Vivo Correlation Of Amorphous Solid Dispersion Enabled Itraconazole Tablets.Pharmaceutical research · 2025Article
- Conventional vs Mechanistic IVIVC: A Comparative Study in Establishing Dissolution Safe Space for Extended Release Formulations.AAPS PharmSciTech · 2024Article
- Modification of small dissolution chamber system for long-acting periodontal drug product evaluation.International journal of pharmaceutics · 2022Article
- A New Saquinavir Mesylate-Sodium Decyl Sulfate Salt Discovered by Serendipity during an Anomalous Dissolution Test.Pharmaceutical research · 2022Article
- Particle Forming Amorphous Solid Dispersions: A Mechanistic Randomized Pharmacokinetic Study in Humans.Pharmaceutics · 2021Article
- In Vitro-In Vivo Correlation (IVIVC) Population Modeling for the In Silico Bioequivalence of a Long-Acting Release Formulation of Progesterone.Pharmaceutics · 2021Article
- Extemporaneous Compounding and Physiological Modeling of Amlodipine/Valsartan Suspension.International journal of hypertension · 2021Article
- In Vitro Dissolution and in Silico Modeling Shortcuts in Bioequivalence Testing.Pharmaceutics · 2020Review
- Application of Pharmacokinetic-Pharmacodynamic Modeling in Drug Delivery: Development and Challenges.Frontiers in pharmacology · 2020Review
- In Silico Prediction of Plasma Concentrations of Fluconazole Capsules with Different Dissolution Profiles and Bioequivalence Study Using Population Simulation.Pharmaceutics · 2019Article
- Development of a Clinically Relevant Dissolution Method for Metaxalone Immediate Release Formulations Based on an IVIVC Model.Pharmaceutical research · 2018Article
- Characterising Drug Release from Immediate-Release Formulations of a Poorly Soluble Compound, Basmisanil, Through Absorption Modelling and Dissolution Testing.The AAPS journal · 2017Article
- Application of Absorption Modeling in Rational Design of Drug Product Under Quality-by-Design Paradigm.The AAPS journal · 2015Article
- Azithromycin cationic non-lecithoid nano/microparticles improve bioavailability and targeting efficiency.Pharmaceutical research · 2014Article
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The aim of the present work was to use GastroPlus™ software for the prediction of pharmacokinetic profiles and in vitro-in vivo correlation (IVIVC) as tools to optimize the development of new generic medications. GastroPlus™ was used to simulate the gastrointestinal compartment and was based on the advanced compartmental absorption and transit model. Powder dissolution and efavirenz tablet dissolution studies were carried out to generate data from which correlation was established. The simulated plasma profile, based on the physicochemical properties of efavirenz, was almost identical to that observed in vivo for biobatches A and B. A level A IVIVC was established for the dissolution method obtained for the generic candidate using the Wagner-Nelson (r (2) = 0.85) and for Loo-Riegelman models (r(2) = 0.92). The percentage of fraction absorbed indicated that 0.5% sodium lauryl sulfate may be considered a biorelevant dissolution medium for efavirenz tablets. The simulation of gastrointestinal bioavailability and IVIVC obtained from immediate-release tablet formulations suggests that GastroPlus™ is a valuable in silico method for IVIVC and for studies directed at developing formulations of class II drugs.
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Registered trials
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