A Physiologically Based Pharmacokinetic (PBPK) Study to Assess the Adjuvanticity of Three Peptides in an Oral Vaccine

A Physiologically Based Pharmacokinetic (PBPK) Study to Assess the Adjuvanticity of Three Peptides in an Oral Vaccine

Publication: Pharmaceutics
Software: GastroPlus®

Following up on the first PBPK model for an oral vaccine built for alpha-tocopherol, three peptides are explored in this article to verify if they could support an oral vaccine formulation as adjuvants using the same PBPK modeling approach.

Systematic Development of Hot Melt Extrusion-Based Amorphous Solid Dispersion: Integrating Quality by Design and In Silico Modeling

Systematic Development of Hot Melt Extrusion-Based Amorphous Solid Dispersion: Integrating Quality by Design and In Silico Modeling

Publication: J Pharm Inov
Software: GastroPlus®

The study aimed to develop and optimize apremilast (APST) solid dispersion formulations using copovidone (Kollidon VA64) as the carrier and vitamin E TPGS as the surfactant to enhance solubility and dissolution, and to utilize in silico Physiologically Based Biopharmaceutics Modeling (PBBM) in GastroPlus to simulate the in vivo behaviour of the optimized formulation, predicting its potential for enhancing oral bioavailability.

In Silico Technologies A Strategic Imperative for Accelerating Breakthroughs and Market Leadership for FDA-regulated Products

In Silico Technologies A Strategic Imperative for Accelerating Breakthroughs and Market Leadership for FDA-regulated Products

Publication: Reagan-Udall Foundation for the Food and Drug Administration
Software: DILIsym®

The 21st century technology revolution has the power to reshape the way organizations manage, process, and harness data, drive innovation, and unlock new possibilities for consumers and patients across the globe

Conventional vs Mechanistic IVIVC: A Comparative Study in Establishing Dissolution Safe Space for Extended Release Formulations

Conventional vs Mechanistic IVIVC: A Comparative Study in Establishing Dissolution Safe Space for Extended Release Formulations

Publication: AAPS PharmSciTech
Software: GastroPlus®

The use of in vitro-in vivo correlation (IVIVC) for extended release oral dosage forms is an important technique that can avoid potential clinical studies.

Construction of a physiologically based pharmacokinetic model of paclobutrazol and exposure estimation in the human body

Construction of a physiologically based pharmacokinetic model of paclobutrazol and exposure estimation in the human body

Publication: Toxicology
Software: GastroPlus®

Paclobutrazol (PBZ) is a plant growth regulator that can delay plant growth and improve plant resistance and yield. Although it has been widely used in the growth of medicinal plants, human beings may take it by taking traditional Chinese medicine.

Evaluating gender effect in the generic bioequivalence studies by physiologically based pharmacokinetic modeling – A case study of dextromethorphan modified release tablets

Evaluating gender effect in the generic bioequivalence studies by physiologically based pharmacokinetic modeling – A case study of dextromethorphan modified release tablets

Publication: Biopharm Drug Dispos
Software: GastroPlus®

The United States Food and Drug Administration guidelines for the bioequivalence (BE) testing of the generic drug products suggests that there should be an equal proportion of male and female population in the BE study.

Physiologically based absorption modeling to predict the bioequivalence of two apixaban formulations

Physiologically based absorption modeling to predict the bioequivalence of two apixaban formulations

Publication: Clin Transl Sci
Software: GastroPlus®

The equivalence of absorption rates and extents between generic drugs and their reference formulations is crucial for ensuring therapeutic comparability.

Advancing Toxicity Predictions: A Review on in Vitro to in Vivo Extrapolation in Next-Generation Risk Assessment

Advancing Toxicity Predictions: A Review on in Vitro to in Vivo Extrapolation in Next-Generation Risk Assessment

Authors: Han P, Li X, Yang J, Zhang Y, Chen J
Publication: Environment & Health
Software: GastroPlus®

As a key step in next-generation risk assessment (NGRA), in vitro to in vivo extrapolation (IVIVE) aims to mobilize a mechanism-based understanding of toxicology to translate bioactive chemical concentrations obtained from in vitro assays to corresponding exposures likely to induce bioactivity in vivo.

In Vitro In Vivo Extrapolation and Bioequivalence Prediction for Immediate-Release Capsules of Cefadroxil Based on a Physiologically-Based Pharmacokinetic ACAT Model

In Vitro In Vivo Extrapolation and Bioequivalence Prediction for Immediate-Release Capsules of Cefadroxil Based on a Physiologically-Based Pharmacokinetic ACAT Model

Authors: Rahim N, Naqvi SBS
Publication: AAPS PharmSciTech
Software: GastroPlus®

Physiologically based pharmacokinetic (PBPK) modeling is a mechanistic concept, which helps to judge the effects of biopharmceutical properties of drug product such as in vitro dissolution on its pharmacokinetic and in vivo performance.

Assessing and mitigating pH-mediated DDI risks in drug development – formulation approaches and clinical considerations

Assessing and mitigating pH-mediated DDI risks in drug development – formulation approaches and clinical considerations

Publication: Drug Metab Rev
Software: GastroPlus®

pH-mediated drug-drug interactions (DDI) is a prevalent DDI in drug development, especially for weak base compounds with highly pH-dependent solubility.

HSPiP, Computational, and Thermodynamic Model–Based Optimized Solvents for Subcutaneous Delivery of Tolterodine Tartrate and GastroPlus-Based In Vivo Prediction in Humans: Part I

HSPiP, Computational, and Thermodynamic Model–Based Optimized Solvents for Subcutaneous Delivery of Tolterodine Tartrate and GastroPlus-Based In Vivo Prediction in Humans: Part I

Publication: AAPS PharmSciTech
Software: GastroPlus®

Tolterodine tartrate (TOTA) is associated with adverse effect, high hepatic access, varied bioavailability, slight aqueous solubility, and short half-life after oral delivery.

From Pipeline to Plant Protection Products: Using New Approach Methodologies (NAMs) in Agrochemical Safety Assessment

From Pipeline to Plant Protection Products: Using New Approach Methodologies (NAMs) in Agrochemical Safety Assessment

Publication: J Agric Food Chem
Software: GastroPlus®

The human population will be approximately 9.7 billion by 2050, and food security has been identified as one of the key issues facing the global population.

Can in vitro/in silico tools improve colonic concentration estimations for oral extended-release formulations? A case study with upadacitinib

Can in vitro/in silico tools improve colonic concentration estimations for oral extended-release formulations? A case study with upadacitinib

Publication: J Control Release
Software: GastroPlus®

Upadacitinib, classified as a highly soluble drug, is commercially marketed as RINVOQ®, a modified-release formulation incorporating hydroxypropyl methylcellulose as a matrix system to target extended release throughout the gastrointestinal (GI) tract.

Prediction of physicochemical and pharmacokinetic properties of botanical constituents by computational models

Prediction of physicochemical and pharmacokinetic properties of botanical constituents by computational models

Publication: J Appl Toxicol
Software: GastroPlus®
Division: PBPK

Botanicals contain complex mixtures of chemicals most of which lack pharmacokinetic data in humans.

Effect of Food Composition on the PK of Isoniazid Quantitatively Explained Using Physiologically Based Biopharmaceutics Modeling

Effect of Food Composition on the PK of Isoniazid Quantitatively Explained Using Physiologically Based Biopharmaceutics Modeling

Division: PBPK

This work shows the utilization of a physiologically based biopharmaceutics model (PBBM) to mechanistically explain the impact of diverse food types on the pharmacokinetics (PK) of isoniazid (INH) and acetyl-isoniazid (Ac-INH).

Development of Mechanistic In Vitro-In Vivo Extrapolation to Support Bioequivalence Assessment of Long-Acting Injectables

Development of Mechanistic In Vitro-In Vivo Extrapolation to Support Bioequivalence Assessment of Long-Acting Injectables

Publication: Pharmaceutics
Software: GastroPlus®
Division: PBPK

Long-acting injectable (LAI) formulations provide sustained drug release over an extended period ranging from weeks to several months to improve efficacy, safety, and compliance.