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.