Accurate Prediction of Liver Fat Reductions Across Range of Weight Loss by Quantitative Systems Pharmacology Modeling

Accurate Prediction of Liver Fat Reductions Across Range of Weight Loss by Quantitative Systems Pharmacology Modeling

Conference: AASLD
Software: NAFLDsym®

Weight loss has positive effects on reducing hepatic lipid burden in MASH patients. Reports using various...

Ocular Drug Discovery & Development: How Modeling & Simulation is Driving and Optimizing Complex Formulations

Ocular Drug Discovery & Development: How Modeling & Simulation is Driving and Optimizing Complex Formulations

Software: GastroPlus®
Division: PBPK

The development of ophthalmic drug products is challenging due to the complexity of the ocular system, the lack of sensitive testing to evaluate the interplay of its physiology with ophthalmic drugs, and measurement limitations associated with ocular pharmacokinetics.

Erectile Dysfunction Therapy of Bariatric Patients: Tadalafil Biopharmaceutics and Pharmacokinetics Before vs. After Gastric Sleeve/Bypass

Erectile Dysfunction Therapy of Bariatric Patients: Tadalafil Biopharmaceutics and Pharmacokinetics Before vs. After Gastric Sleeve/Bypass

Publication: AAPS J
Software: GastroPlus®
Division: PBPK

Bariatric surgery introduces significant changes in the gastrointestinal tract, which may affect oral drug absorption/bioavailability.

Quantitative Systems Toxicology Modeling of Otenaproxesul Liver Enzyme Elevations Leads to Prediction of Liver Safety for Acute Otenaproxesul Dosing

Quantitative Systems Toxicology Modeling of Otenaproxesul Liver Enzyme Elevations Leads to Prediction of Liver Safety for Acute Otenaproxesul Dosing

Conference: ACoP
Software: DILIsym®

Otenaproxesul (ATB-346), a drug that combines naproxen with a thiobenzamide antioxidant, is being developed as an NSAID that reduces gut toxicity effects. Liver...

Weight Loss and Nausea from Subcutaneous and Oral Semaglutide Accurately Simulated with a QSP Model

Weight Loss and Nausea from Subcutaneous and Oral Semaglutide Accurately Simulated with a QSP Model

Conference: ACoP
Software: OBESITYsym

The recent availability of effective GLP-1R agonist (GLP-1RA) based treatments of obesity has provided great benefit to patients. Understanding the balance between body weight (BW) loss...

Evaluation of Drug–Drug Interactions Between Clarithromycin and Direct Oral Anticoagulants Using Physiologically Based Pharmacokinetic Models

Evaluation of Drug–Drug Interactions Between Clarithromycin and Direct Oral Anticoagulants Using Physiologically Based Pharmacokinetic Models

Authors: Yang Z, Qu Y, Sun Y, Pan J, Zhou T, Yu Y
Publication: Pharmaceutics
Software: GastroPlus®
Division: PBPK

This study assessed the pharmacokinetic (PK) interactions between clarithromycin (a P-glycoprotein [P-gp] inhibitor) and four direct oral anticoagulants (DOACs) (P-gp substrates) using physiologically based PK (PBPK) models to elucidate the influence of P-gp in the interaction between them. 

Discovery of Penicillic Acid as a Chemical Probe Against Tau Aggregation in Alzheimer’s Disease

Discovery of Penicillic Acid as a Chemical Probe Against Tau Aggregation in Alzheimer’s Disease

Publication: Chemical Science
Software: ADMET Predictor®
Division: Cheminformatics

Alzheimer's Disease (AD) is a neurodegenerative disorder proven to be caused by the aggregation of protein tau into fibrils, resulting in neuronal death.

Weight Loss and Nausea from Subcutaneous and Oral Semaglutide Accurately Simulated with a QSP Model

Weight Loss and Nausea from Subcutaneous and Oral Semaglutide Accurately Simulated with a QSP Model

Conference: ACoP

The availability of effective GLP-1 receptor agonists (GLP-1RAs) for obesity treatment has greatly benefited patients. Balancing body weight (BW) loss with nausea is crucial to predict the effectiveness of these medications, along with understanding the impact of delivery methods. Quantitative Systems Pharmacology (QSP) modeling helps predict efficacy and adverse events, assessing key differences and similarities between treatment protocols.

Physiologically-Based Pharmacokinetic Modeling of Trofinetide in Moderate Renal Impairment for Phase 1 Clinical Study Dose Selection with Model Validation

Physiologically-Based Pharmacokinetic Modeling of Trofinetide in Moderate Renal Impairment for Phase 1 Clinical Study Dose Selection with Model Validation

Publication: Eur J Drug Metab Pharmacokinet
Software: GastroPlus®
Division: PBPK

Trofinetide, the first approved treatment for Rett syndrome (RTT), is primarily excreted unchanged in the urine; therefore, it is important to assess the extent to which the exposure is affected in patients with renal impairment.