Modeling of Active Transport and Metabolism for Hepatocyte Assays with Application of In Vitro to In Vivo Extrapolation (IVIVE)

Modeling of Active Transport and Metabolism for Hepatocyte Assays with Application of In Vitro to In Vivo Extrapolation (IVIVE)

Conference: AAPS
Software: MembranePlus™

Sandwich and suspended hepatocyte cultures are routinely used to assess either active transport and/or metabolism of drug molecules. 

Development of In Vitro-In Vivo Correlation for Long Acting Injectable Microsphere Formulations

Development of In Vitro-In Vivo Correlation for Long Acting Injectable Microsphere Formulations

Conference: AAPS
Software: GastroPlus®
Division: PBPK

The concept of in vitro-in vivo correlations (IVIVCs) for long-acting injectable (LAI) microsphere formulations has gained more significance in the past decade.

Application of Physiologically Based Pharmacokinetic (PBPK) Models in Predicting Drug Pharmacokinetics for Different Ethnic Groups

Application of Physiologically Based Pharmacokinetic (PBPK) Models in Predicting Drug Pharmacokinetics for Different Ethnic Groups

Conference: AAPS
Software: GastroPlus®
Division: PBPK

The purpose of this study was to evaluate the ability of PBPK models to predict the pharmacokinects (PK) of different compounds in two ethnic groups, Caucasian and Chinese.

Ribociclib Bioavailability Is Not Affected by Gastric pH Changes or Food Intake: In Silico and Clinical Evaluations.

Ribociclib Bioavailability Is Not Affected by Gastric pH Changes or Food Intake: In Silico and Clinical Evaluations.

Publication: Clin Pharmacol Ther
Software: GastroPlus®

Ribociclib (KISQALI®), a cyclin-dependent kinase 4/6 inhibitor approved for the first-line treatment of HR+/HER2– advanced breast cancer with an aromatase inhibitor, is administered with...

Intrinsic dissolution simulation of highly and poorly soluble drugs for BCS solubility classification

Intrinsic dissolution simulation of highly and poorly soluble drugs for BCS solubility classification

Publication: Dissolut Technol
Software: DDDPlus™

Intrinsic dissolution testing allows characterizing drug substances through its dissolution rate when exposed to a specified surface area in a specific dissolution media.

Combining “Bottom-up” and “Top-down” Approaches to Assess the Impact of Food and Gastric pH on Pictilisib (GDC-0941) Pharmacokinetics

Combining “Bottom-up” and “Top-down” Approaches to Assess the Impact of Food and Gastric pH on Pictilisib (GDC-0941) Pharmacokinetics

Publication: CPT Pharmacometrics Syst Pharmacol
Software: GastroPlus®
Division: PBPK

Pictilisib, a weakly basic compound, is an orally administered, potent, and selective pan-inhibitor of phosphatidylinositol 3-kinases for oncology indications.

Predictive Biopharmaceutics and Pharmacokinetics: Modeling and Simulation

Predictive Biopharmaceutics and Pharmacokinetics: Modeling and Simulation

Publication: Developing solid oral dosage forms : pharmaceutical theory & practice
Software: GastroPlus®

Scientists have made great discoveries concerning human physiology and gained tremendous knowledge during drug development efforts.

Investigating the state of physiologically based kinetic modelling practices and challenges associated with gaining regulatory acceptance of model applications.

Investigating the state of physiologically based kinetic modelling practices and challenges associated with gaining regulatory acceptance of model applications.

Publication: Regul Toxicol Pharmacol
Software: GastroPlus®

Physiologically based kinetic (PBK) models are used widely throughout a number of working sectors, including academia and industry, to provide insight into the dosimetry related to observed adverse...