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.

Integrating Human Biomimetic Liver Microphysiology System with Quantitative Systems Toxicology Modeling to Predict DILI

Integrating Human Biomimetic Liver Microphysiology System with Quantitative Systems Toxicology Modeling to Predict DILI

Authors: Yang K
Conference: Drug-Induced Liver Injury Conference
Software: DILIsym®

Integrating Human Biomimetic Liver Microphysiology System with Quantitative Systems Toxicology Modeling to Predict DILI