A Rapid Method to Estimate Hepatocyte Loss Due to Drug‐Induced Liver Injury

A Rapid Method to Estimate Hepatocyte Loss Due to Drug‐Induced Liver Injury

Publication: Clin Pharmacol Ther
Software: DILIsym®

It is not currently possible to rapidly estimate the extent of hepatocyte loss during drug‐induced liver injury (DILI). We used a proprietary mechanistic model (DILIsym) to estimate percentage hepatocyte loss due...

Pharmacokinetics, tissue distribution and excretion of ACT001 in Sprague-Dawley rats and metabolism of ACT001

Pharmacokinetics, tissue distribution and excretion of ACT001 in Sprague-Dawley rats and metabolism of ACT001

Publication: J Chromatogr B
Software: ADMET Predictor®

This study investigated pharmacokinetics, tissue distribution and excretion of ACT001 in Sprague-Dawley rats. Stability study and metabolism study of ACT001 are conducted.

Zonal Hepatic Stellate Cell (HSC) Activation in Nonalcoholic Steatohepatitis (NASH) Characterized by A Mathematical Model

Zonal Hepatic Stellate Cell (HSC) Activation in Nonalcoholic Steatohepatitis (NASH) Characterized by A Mathematical Model

Conference: AASLD
Software: NAFLDsym®

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

Quantitative Systems Toxicology (QST) Supports Differentiated Liver Safety for a Next-in-Class Compound

Conference: AASLD
Software: DILIsym®

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

Using Quantitative Systems Pharmacology Modeling to Understand the Effects of Acetyl CoA Carboxylase (ACC) Inhibition on Liver and Plasma Triglycerides in a Simulated Population

Conference: AASLD
Software: NAFLDsym®

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

In Vitro to In Vivo Extrapolation (IVIVE) of Itraconazole Precipitation using a Biphasic Dissolution Test and Mechanistic Absorption Model

Conference: AAPS
Division: PBPK

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.

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™

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™

Publication: J Pharm Biomed Anal
Software: 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)

Liver Safety Comparison of Two Treatments for Autosomal-Dominant Polycystic Kidney Disease (ADPKD) Using Quantitative Systems Toxicology Software (DILIsym)

Conference: AAPS
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

Assessing the Role of Intracellular Binding Protein in Drug-Induced Bile Acid Transporter Inhibition Using Quantitative Systems Pharmacology (QSP) Modeling

Conference: AAPS
Software: DILIsym®

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.

A PBPK model of the negative effect of chitosan on acyclovir absorption: The mucus-chitosan interaction

A PBPK model of the negative effect of chitosan on acyclovir absorption: The mucus-chitosan interaction

Conference: AAPS
Software: GastroPlus®
Division: PBPK

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

HTPK: Conducting PK modeling and simulations at high speed

Conference: AAPS
Software: ADMET Predictor®
Division: PBPK

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: Conducting PK modeling and simulations at high speed

Conference: AAPS
Division: PBPK

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

Using in-silico Models to Integrate in-vitro Data to Support Virtual Trials for Cost Effective Drug Development

Authors: Lukacova V
Conference: AAPS
Software: GastroPlus®
Division: PBPK

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.