Non-alcoholic fatty liver disease (NAFLD) represents a spectrum of pathophysiology, ranging from hepatic steatosis, through non-alcoholic steatohepatitis (NASH) and hepatic fibrosis, and in rare cases resulting in cirrhosis and liver failure.

Quantitative Systems Toxicology (QST) Supports Differentiated Liver Safety for a Next-in-Class Compound
Lixivaptan, a vasopressin-2 receptor antagonist, is under development for the treatment of autosomal dominant polycystic kidney disease (ADPKD), an orphan disease with minimal treatment options.

Using Quantitative Systems Pharmacology Modeling to Understand the Effects of Acetyl CoA Carboxylase (ACC) Inhibition on Liver and Plasma Triglycerides in a Simulated Population
Treatment options for nonalcoholic steatohepatitis (NASH) are limited. One approach targets hepatic acetyl-CoA carboxylase (ACC), which influences de novo lipogenesis (DNL) and fatty acid oxidation.

In Vitro to In Vivo Extrapolation (IVIVE) of Itraconazole Precipitation using a Biphasic Dissolution Test and Mechanistic Absorption Model
Regulatory agencies have encouraged the use of mechanistic absorption (MAM) and physiologically-based pharmacokinetic (PBPK) modeling to reduce cost and time to market for new and generic drug products.

A Physiologically Based Pharmacokinetic Model of Rivaroxaban: Role of OAT3 and P-gp Transporters in Renal Clearance
Rivaroxaban is an oral anticoagulant which acts by inhibiting factor Xa of the coagulation network.

Simulations Plus to Report 4th Quarter and Fiscal Year 2018 Financial Results
Conference Call to be on Wednesday, November 14, 2018, at 4:15 PM ET

Mechanisms Underlying Species Differences in Hepatotoxicity
Quantitative Systems Toxicology (QST) modeling can explain and predict species differences in dose-dependent hepatotoxicity.

DILIsym Services, an SLP Company, Launches Consortium for Drug-Related Kidney Injury
RENAsym consortium will use QST to predict and investigate drug-induced kidney injury across various patient groups

Enzyme and Transporter Expression Levels in GastroPlus® 9.6
This video discusses the enzyme and transporter expression levels that are defined in various tissues, e.g., GI tract, liver, lung, kidney and species (human, dog, monkey, and rat).

In vitro and in vivo investigation of metabolic fate of riociguat by HPLC-Q-TOF/MS/MS and in silico evaluation of the metabolites by ADMET Predictor™
Riociguat, a guanyl cyclase inhibitor, is one of its kind drug regimen approved for management of pulmonary arterial hypertension and chronic thromboembolism pulmonary hypertension.

Liver Safety Comparison of Two Treatments for Autosomal-Dominant Polycystic Kidney Disease (ADPKD) Using Quantitative Systems Toxicology Software (DILIsym)
Lixivaptan, a vasopressin-2 receptor antagonist, is being developed for the treatment of autosomal-dominant polycystic kidney disease (ADPKD), an orphan disease that is an unmet medical need.

Assessing the Role of Intracellular Binding Protein in Drug-Induced Bile Acid Transporter Inhibition Using Quantitative Systems Pharmacology (QSP) Modeling
Bile acid transporter inhibition has been shown to be an important mechanism of drug-induced liver injury (DILI), but the biophase responsible for the transporter inhibition is unclear.

Assessing the Role of Intracellular Binding Protein in Drug-Induced Bile Acid Transporter Inhibition Using QuantiativeSystems Pharmacology (QSP) Modeling
DILIsym Is Used to Predict Bile-Acid Mediated Drug-Induced Liver Injury

A PBPK model of the negative effect of chitosan on acyclovir absorption: The mucus-chitosan interaction
A recent bioavailability study raises questions about the universality of the permeability enhancing effect of chitosan on poorly permeable drugs.

HTPK: Conducting PK modeling and simulations at high speed
In silico pharmacokinetic (PK) simulations are now routinely incorporated into drug development workflows, especially in the later stages.

HTPK: Conducting PK modeling and simulations at high speed
HTPK lightens the burden of collecting and preparing input variables for full blown PK simulations by using structure-based predictions.

Using in-silico Models to Integrate in-vitro Data to Support Virtual Trials for Cost Effective Drug Development
PBPK models allow incorporating different types of in vitro measurements into single platform to account for all processes affecting drug’s absorption, distribution and elimination.

Integration of Precipitation Kinetics From an In vitro, Multicompartment Transfer System and Mechanistic Oral Absorption Modeling for Pharmacokinetic Prediction of Weakly Basic Drugs
Solubility, dissolution, and precipitation in the gastrointestinal tract can be critical for the oral bioavailability of weakly basic drugs.

Application of a Dynamic Fluid & pH Model to Simulate Intraluminal and Systemic Concentrations of a Weak Base in GastroPlus™
The application of preclinical in vitro and in silico models can help formulation scientists to predict the in vivo performance of a drug in an early stage of oral drug product development.

In Silico Simulation of Dissolution Profiles for Development of Extended-Release Doxazosin Tablets
Developing extended-release (ER) formulations with appropriate release characteristics can be challenging for formulation scientists.