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.