Population pharmacokinetic modeling of daridorexant, a novel dual orexin receptor antagonist

Population pharmacokinetic modeling of daridorexant, a novel dual orexin receptor antagonist

Publication: CPT Pharmacometrics Syst Pharmacol

The analysis aimed at identifying subject-specific characteristics (covariates) influ-encing exposure to daridorexant and quantification of covariate effects to determineclinical relevance.

Pimavanserin exposure–response analyses in patients with schizophrenia: results from the phase 2 ADVANCE study

Pimavanserin exposure–response analyses in patients with schizophrenia: results from the phase 2 ADVANCE study

Publication: Journal of Clinical Psychopharmacology

Pimavanserin is a selective serotonin 5-HT2A receptor inverse agonist/antagonist being investigated in patients with negative symptoms of schizophrenia. This analysis aimed to characterize exposure-response relationships of...

Evaluating the bioequivalence of two pitavastatin calcium formulations based on IVIVC modeling and clinical study

Evaluating the bioequivalence of two pitavastatin calcium formulations based on IVIVC modeling and clinical study

Publication: Clin Transl Sci
Software: GastroPlus®

In vitro-in vivo correlation (IVIVC) allows prediction of the in vivo performance of a pharmaceutical product based on its in vitro drug release profiles...

Delineating the Complex Interplay of Enzymes and Transporters Governing the Absorption and Disposition of Atorvastatin and the Metabolites Using Physiologically Based Pharmacokinetic (PBPK) Modeling

Delineating the Complex Interplay of Enzymes and Transporters Governing the Absorption and Disposition of Atorvastatin and the Metabolites Using Physiologically Based Pharmacokinetic (PBPK) Modeling

Conference: ISSX
Software: GastroPlus®
Division: PBPK

Atorvastatin (ATS) is widely used to treat high cholesterol and potentially lower the risk of cardiac complications.

Clinical Ocular Exposure Extrapolation for Ophthalmic Solutions Using PBPK Modeling and Simulation

Clinical Ocular Exposure Extrapolation for Ophthalmic Solutions Using PBPK Modeling and Simulation

Publication: Pharmaceutical Research
Software: GastroPlus®
Division: PBPK

The development of generic ophthalmic drug products is challenging due to the complexity of the ocular system, and a lack of sensitive testing to evaluate the interplay of physiology with ophthalmic formulations.

Results from a Validated in vitro Gastrointestinal Model (TIM) used as input Data for in silico Modeling Give Highly Predictive Information for the Human Situation

Results from a Validated in vitro Gastrointestinal Model (TIM) used as input Data for in silico Modeling Give Highly Predictive Information for the Human Situation

Publication: Medical Research Archives
Software: GastroPlus®
Division: PBPK

The aim of this review paper is to evaluate the predictive quality of a combination of in vitro dynamic gastrointestinal models, mucosal transit models and in silico kinetic...

Translational pharmacokinetics of a novel bispecific antibody against Ebola virus (MBS77E) from animal to human by PBPK modeling & simulation

Translational pharmacokinetics of a novel bispecific antibody against Ebola virus (MBS77E) from animal to human by PBPK modeling & simulation

Publication: Int J Pharm
Software: GastroPlus®
Therapeutic Areas: Biologics

The goal of this study was to construct a PBPK model to accelerate the translation of MBS77E, a humanized bispecific antibody against the Ebola virus.

GastroPlus as an Educational Tool Teaching of Pharmacokinetics & Biopharmaceutics with PBPK Modeling

GastroPlus as an Educational Tool Teaching of Pharmacokinetics & Biopharmaceutics with PBPK Modeling

Software: GastroPlus®
Division: PBPK

Students have an increased interest in learning physiologically based pharmacokinetic (PBPK) modeling, but this requires an in-depth understanding of biopharmaceutics and pharmacokinetics.

Gastrointestinal Fluid Volumes in Pediatrics: A Retrospective MRI Study

Gastrointestinal Fluid Volumes in Pediatrics: A Retrospective MRI Study

Publication: Pharmaceutics
Software: GastroPlus®

The volume and distribution of fluids available in the gastrointestinal (GI) tract may substantially affect oral drug absorption.

A phase 1b dose escalation study of CD137 mAb agonist OC-001 as monotherapy in patients with advanced or metastatic cancer

A phase 1b dose escalation study of CD137 mAb agonist OC-001 as monotherapy in patients with advanced or metastatic cancer

Conference: European Society for Medical Oncology (ESMO)

OC-001 is a CD137 mAb agonist designed to show differential agonistic activity from that of competitor
antibodies. OC-001 provided T cell activation that