Biologics address a range of unmet medical needs. However, there are
increasing numbers of BILI cases which slow therapeutic development...
Simulating Multidrug Resistance Protein 3 (MDR3) Inhibition-Mediated Cholestatic Liver Injury Using DILIsym X, a Quantitative Systems Toxicology (QST) Modeling Platform
Inhibition of efflux transporters located on the canalicular membrane of hepatocytes is an important mechanism of cholestatic liver injury, which is...
Quantitative Systems Toxicology (QST) Modeling of Cimaglermin Alfa (GGF2) Hepatotoxicity Shows the Potential of BIOLOGXsym to Predict Biologics-Induced Liver Injury (BILI)
Biologics continue to address various unmet medical needs, but the occurrence of BILI can terminate clinical...
Modeling of Indinavir-Induced Crystal Nephropathy in RENAsym®
Indinavir, a protease inhibitor used to treat patients with HIV/AIDS, is known to induce crystal nephropathy. This is...
Evaluating Nephrotoxicity of Cisplatin in Rats with RENAsym, a Mechanistic Model of Drug-Induced Acute Kidney Injury
Acute kidney injury (AKI) is often initiated by cellular toxicity of proximal tubule epithelial cells (PTEC) when...
Furthering the clinical development of navicixizumab in advanced epithelial ovarian cancer patients with a population pharmacokinetic model and exploratory exposure-safety-efficacy response analyses
Navicixizumab is a first-in-class, bispecific, anti-angiogenic antibody to vascular endothelial growth factor (VEGF) and
Using artificial intelligence to design BACE1 inhibitors
β-secretase 1 (BACE1) is an enzyme involved in production of amyloid-βpeptides, which are involved in the pathology of Alzheimer’s disease.
Quantitative Systems Pharmacology Modeling of FGF19 Pathway Using NAFLDsym Prospectively Predicted Liver Fat and Serum Biomarker Responses to MET409 in NASH Patients
Treatment of nonalcoholic steatohepatitis (NASH) is a significant unmet medical need. In this work...
Proof-of-concept Simulations Using BIOLOGXsym, a Novel Quantitative Systems Toxicology (QST) Modeling Platform for Predicting Biologics-induced Liver Injury (BILI), Recapitulate Clinically Observed Hepatotoxicity of GGF2
While biologics continue to address various unmet medical needs, BILI can terminate clinical development...
Population pharmacokinetic modeling and stochastic simulations to support pediatric dose selection of pimavanserin
pimavanserin-is-a-selective-serotonin-receptor-modulating-agent-with-inverse-agonist-antagonist-activity-at-the-5ht2a-receptor-and-to-a-lesser
Validation of non-compartmental analysis (NCA) and bioequivalence results of PKanalix with respect to Phoenix WinNonLin
Non-compartmental analysis (NCA) is used at all stages of drug development and is a key method to understand the pharmacokinetic properties of a compound.
Quantitative Systems Pharmacology (QSP) Model Predicts Lack of Efficacy for Cenicriviroc, a CCR2/5 Antagonist, in NAFLD/NASH Patients
A phase 3 clinical trial (AURORA) for cenicriviroc (CVC), a CC chemokine receptor 2 and 5 (CCR2/5) antagonist, was recently...
Advancing Calcitonin Gene-Related Peptide Receptor Antagonists Using Quantitative Systems Toxicology Modeling to Characterize Next-in-Class Compounds Compared to the Hepatotoxic First in Class Telcagepant
While CGRP receptor antagonists have demonstrated efficacy in the acute and preventive treatment of migraine...
Yo-Yo Dieting Predicted to Contribute to Fibrosis Score Reductions in Untreated (Placebo) Cohorts
10-25% of the patients in placebo cohorts in NASH clinical trials (0.5-2 years) have fibrosis score reductions.
Suppressing TGF-β activation to reduce lung fibrosis: In search for an efficacious dose regimen for alpha V integrin inhibitors
Elevated levels of TGF-β and specifically its activated form is regarded as one of the disease drivers in patients with idiopathic pulmonary fibrosis (IPF).
A library of parent –metabolite models for the MonolixSuite
Ready to use large combination of models integrated in MonolixSuite 2021 with modular filters -a simple workflow to help you test many different hypothesis.
Population Pharmacokinetics Analysis for Molnupiravir in Adults with COVID-19
There is an urgent need for safe and effective oral treatments for COVID-19 that reduce progression to severe illness and risk of hospitalization or death
Optimizing the sample size of a bridging study using Simulx, an application of the MonolixSuite
Plan a bridging study for approval in China
CARDIOsym QSP model prediction of wound healing response following myocardial infarction
Objectives: Cardiac wound healing post-myocardial infarction represents a complex balance between inflammation and fibrosis (Richardson 2017). A biphasic...
Quantitative Systems Toxicology (QST) Modeling of Drug-Induced Acute Proximal Tubule Epithelial Cell Injury and Associated Renal Hemodynamic Responses
Renal proximal tubule epithelial cells (RPTEC) are vulnerable to drug-induced toxicities which often result in acute kidney...