Toxicity is a measure of any unfavourable or negative impact of substances.

Simulations Plus Names Sharlene Evans to Board of Directors
Experienced Human Resource, Development and Organizational Leader Bolsters Board

Simulations Plus Presented Breakthrough Scientific Data at Top Liver Disease Conference
Yo-Yo dieting without additional treatment can explain high placebo response rates in NASH clinical trials

Application of PBPK modeling & simulation to support dose selection in special populations – Bilastine as a case example
Dose recommendations are usually established using data driven approaches, i.e., population modeling & simulation...

November 2021 GastroPlus Newsletter
Only 52 days left in 2021!

Simulations Plus Releases RENAsym® Version 1A Software for Kidney Injury
New RENAsym platform helps drug developers avoid kidney injury side effects

Simulations Plus Releases RENAsym® Version 1A Software for Kidney Injury
Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that its DILIsym...

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.

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...