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...
Mechanistic Modeling of Kidney-Injury Molecule 1 (KIM-1) as a biomarker for Cisplatin-Induced Acute Kidney Injury
Kidney Injury Molecule 1 (KIM-1) is a specific and sensitive biomarker for drug-induced kidney injury (AKI) prediction...
Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Levofloxacin Solution Case Study
Development of generic ophthalmic drug products is challenging due to the complexity of the ocular system and a lack of sensitive testing tools to evaluate its interplay with ophthalmic formulations
Assessing the Potential for Hepatotoxicity for Combination Therapy of Valproate (VPA) and Cannabidiol (CBD) using Quantitative Systems Toxicology (QST)
Highly purified cannabidiol (CBD) (approved as Epidiolex in the US) is efficacious in treating seizures associated with Dravet syndrome (DS), Lennox-Gastaut syndrome (LGS), and Tuberous Sclerosis Complex (TSC).
Quantitative Systems Pharmacology Modeling Using NAFLDsym Recapitulated Clinically Observed Histological Responses and Serum Markers to NGM282 in NASH Patients
Nonalcoholic steatohepatitis (NASH) is a growing clinical concern, but currently there is no approved medicine for treatment of NASH. Fibroblast growth...
Gender Related Differences and Pregnancy Induced Changes in Labetalol Glucuronidation Assessed via PBPK Modeling and Simulation
Glucuronidation is considered a major metabolic pathway for drugs containing carboxylic acid, hydroxyl, and amine moieties [1].
Predicting the Efficacy of Obeticholic Acid Treatment for Non-Alcoholic Steatohepatitis (NASH) Using NAFLDsym, a Quantitative Systems Pharmacology Model of Non-Alcoholic Fatty Liver Disease
Obeticholic acid (OCA), a bile acid analog and agonist of the farnesoid X receptor (FXR), is currently in clinical trials...
Relationship Between Pimavanserin Exposure and QTc Interval in Patients with Schizophrenia: Modelling Analysis from Randomized, Double-Blind, Placebo-Controlled Studies
Patients with schizophrenia who are receiving more than one antipsychotic may be at higher risk for QT interval...
Pharmacokinetic Profile of Pimavanserin in Patients With Dementia-Related Psychosis and Concomitant Acetylcholinesterase Inhibitor Use: Modeling Data From the Phase 3 HARMONY Study
Pimavanserin is a selective serotonin-modulating agent with inverse agonist/antagonist activity at the 5HT2A receptor, and to a lesser extent at...
Model-based dose selection for the phase 3 evaluation of molnupiravir (MOV) in the treatment of COVID-19 in adults
There is an urgent need for effective treatment options that are easily administered and readily implementable in health systems globally to reduce the impact of COVID-191
Relationship Between Pimavanserin Exposure and Negative Symptoms in Patients With Schizophrenia: Data Analysis From the Phase 2 ADVANCE Study
Negative symptoms in schizophrenia are associated with poor psychosocial function and long-term outcomes yet no pharmacological treatments are currently approved in the United States to treat...
Using Quantitative Systems Pharmacology Modeling to Understand the Pathophysiology of Idiopathic Pulmonary Fibrosis
Patients with idiopathic pulmonary fibrosis (IPF) have a poor survival prognosis and limited treatment options.
Quantitative Systems Toxicology Modeling Using DILIsym Suggests That Drug-Induced Liver Injury (DILI) Can Be Enhanced by Co-administered Drugs and Mitigated by Mitochondrial Biogenesis
Drug-induced liver injury (DILI) can be enhanced by polypharmacy if co-administered drugs induce toxicity via mechanisms that have overlapping pathways.
A Phase 1b Study of Oral Chk1 Inhibitor LY2880070 as Monotherapy in Patients with Advanced or Metastatic Cancer
In the context of DNA damage, Checkpoint Kinase 1 (Chk1) mediates a checkpoint response which arrests the cell cycle and allows the cell to complete DNA repair and replication.