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.
Physiologically Based Pharmacokinetic Modeling and Dose Adjustment of Teicoplanin in Pediatric Patients With Renal Impairment
The pharmacokinetics of teicoplanin differs in children as compared with adults, and especially in renally impaired pediatric patients.
Foxm1 modulators and uses thereof
Disclosed herein, inter alia, are FOXM1 modulators and methods for modulating the activity of androgen receptors in neuronal cells to treat various diseases, such as spinal-...
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...
Optimized In Silico Modeling of Drug Absorption after Gastric Bypass: The Case of Metformin
Bariatric surgery is an effective treatment for severe obesity and related comorbidities, such as type II diabetes. Gastric bypass surgery shortens the length of the intestine, possibly leading to altered drug absorption.
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...
Prediction of pharmacokinetic parameters of inhaled indacaterol formulation in healthy volunteers using physiologically-based pharmacokinetic (PBPK) model
Inhaled formulations are the first choices for treating asthma and chronic obstructive pulmonary disease (COPD), attracting the increasing investment and development in the...
A Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union
The current regulatory criterion for bioequivalence of narrow therapeutic index (NTI) drugs in the European Union requires that the 90% confidence interval for the ratio of the population geometric means of the test product compared with the reference for area under the plasma concentration-time curve (AUC), and in certain cases maximum plasma drug concentration (Cmax ), to be included within the tighter acceptance range of 90.00-111.11%.
Guiding Principles of Corporate Governance
On October 21, 2021 Simulations Plus, Inc. supports the following core guiding principles of corporate governance.
Estimators and Confidence Intervals of f 2 Using Bootstrap Methodology for the Comparison of Dissolution Profiles
The most widely used method to compare dissolution profiles is the similarity factor f2. When this method is not applicable, the confidence interval of f2 using bootstrap methodology has been recommended instead.
The evaluation of the effect of different superdisintegrants on the drug release from FDM 3D printed tablets through different applied strategies: In vitro-in silico assessment
Paracetamol-loaded tablets were printed by fused deposition modelling technique, using polyvinyl alcohol as a backbone polymer and Affinisol™ HPMC as a plasticizer in all formulations.
Pharmacokinetics of asciminib in the presence of CYP3A or P-gp inhibitors, CYP3A inducers, and acid-reducing agents
Asciminib is a first-in-class inhibitor of BCR::ABL1, specifically targeting the ABL myristoyl pocket. Asciminib is a substrate of CYP3A4 and P-glycoprotein (P-gp) and possesses pH-dependent solubility in aqueous solution.