Phase 1 and pharmacokinetic study of LY3007113, a p38 MAPK inhibitor, in patients with advanced cancer

Phase 1 and pharmacokinetic study of LY3007113, a p38 MAPK inhibitor, in patients with advanced cancer

Publication: Investigational New Drugs
Division: PBPK

Background The signaling protein p38 mitogen-activated protein kinase (MAPK) regulates the tumor cell microenvironment, modulating cell survival, migration, and invasion.

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...

Effect of the pulmonary deposition and in vitro permeability on the prediction of plasma levels of inhaled budesonide formulation

Effect of the pulmonary deposition and in vitro permeability on the prediction of plasma levels of inhaled budesonide formulation

Publication: Int J Pharm
Software: GastroPlus®

The growing interest in the inhalable pharmaceutical products requires advanced approaches to safe and fast product development, such as in silico tools that can be used...

Abstract B083: Population pharmacokinetics and pharmacodynamics for an oral Notch inhibitor, LY3039478, in patients with advanced cancer and healthy volunteers

Abstract B083: Population pharmacokinetics and pharmacodynamics for an oral Notch inhibitor, LY3039478, in patients with advanced cancer and healthy volunteers

Division: PBPK

Background: LY3039478 is an oral Notch inhibitor that prevents release of the Notch Intracellular Domain (NICD) by inhibiting proteolytic activity of the gamma (γ)-secretase complex.

Industry’s View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical Development, Registration, and Commercialization.

Industry’s View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical Development, Registration, and Commercialization.

Publication: J Pharm Sci
Software: GastroPlus®

This article intends to summarize the current views of the IQ Consortium Dissolution Working Group, which comprises various industry companies, on the roles of dissolution testing throughout...

The solubility-permeability trade-off of progesterone with cyclodextrins under physiological conditions: Experimental observations and computer simulations

The solubility-permeability trade-off of progesterone with cyclodextrins under physiological conditions: Experimental observations and computer simulations

Authors: Sun L, Zhang B, Sun J
Publication: J Pharm Sci
Software: GastroPlus®

This study intended to evaluate the effect of cyclodextrins on the apparent solubility and permeability of lipophilic drugs under physiological conditions and establish in silico model to choose...

Pharmacokinetics of Tedizolid in Obese and Nonobese Subjects

Pharmacokinetics of Tedizolid in Obese and Nonobese Subjects

Publication: J Clin Pharmacol

Obesity, defined as body mass index (BMI) 30 kg/m2, is a growing problem worldwide; the prevalence is 38% in the US adult population.