Human-on-a-Chip (HoaC) systems are becoming valuable tools to study, understand disease physiology, and expand the prediction of pharmacodynamic effects before first-in-human studies. They can also be used to evaluate the toxic effects of compounds in non-pharma industries where these effects cannot be examined in vivo.
Scaffold-Hopping Strategy on a Series of Proteasome Inhibitors Led to a Preclinical Candidate for the Treatment of Visceral Leishmaniasis
There is an urgent need for new treatments for visceral leishmaniasis (VL), a parasitic infection which impacts heavily large areas of East Africa, Asia, and South America
IPFsym™ Product Brochure
State of the art QSP software for idiopathic pulmonary fibrosis (IPF)
Simulations Plus Releases ADMET Predictor® (X.2)
Industry-driven enhancements further establish ADMET Predictor® as the preferred platform for discovery PBPK simulations
Early assessment of PK properties using ADMET Predictor® HTPK Simulation Technology
Physiologically-based pharmacokinetic (PBPK) modeling, combined with in vitro and in vivo extrapolation (IVIVE) approaches...
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.
Assessing the Potential for Hepatotoxicity for Combination Therapy of Valproate (VPA) and CBDusing Quantitative Systems Toxicology (QST) DILIsym Correctly Predicts CBD ALT Elevations and Evaluates Interaction Mechanism(s)
Epidiolex (highly purified CBD) is efficacious in treating seizures associated with Dravetsyndrome (DS), Lennox-Gastautsyndrome (LGS), and Tuberous Sclerosis Complex (TSC)
Quantitative Systems Toxicology (QST) to Investigate Mechanisms Contributing to Clinical Bilirubin Elevations
Some patients treated with Drug X experienced elevations in serum bilirubin with concomitant ALT elevations, potentially indicative of severe liver injury.
U.S. FDA Renews Licenses of DILIsym Software
FDA Renewal Allows for Evaluation of DILIsym Submissions by Sponsors
Evaluating the impact of physiological properties of the gastrointestinal tract on drug in vivo performance using Physiologically Based Biopharmaceutics Modeling and virtual clinical trials
The physiological properties of the gastrointestinal tract, such as pH, fluid volume, bile salt concentration, and gastrointestinal transit time, are highly variable in vivo.
Using DDDPlus™ to Predict in vivo API Exposure Levels
There has been an increasing desire to incorporate mechanistic models of in vitro experiments to evaluate the interplay between...
Early assessment of PK properties with the ADMET Predictor® HTPK Simulation module, a high-throughput mechanistic PBPK approach
David Miller, Vice President of Cheminformatics, expands on this PBPK approach with the HTPK module...
Utilization of PBBM/PBPK Models for Building a Safe Space and Regulatory Applications in Support of Drug Product Quality
Sandra Suarez-Sharp, VP of Regulatory Affairs presents to the GastroPlus User Group - the concept of safe space to decrease the regulatory burden...
The GastroPlus® – Additional Dosage Routes Seminar Series
This GastroPlus Seminar series focused on the Additional Dosage Route’s module which goes beyond the traditional oral and intravenous drug...
The GastroPlus® “Workshop from Home” Seminars (April 13-17)
Physiologically based pharmacokinetic modeling & simulation is increasingly used as a tool in drug product development, not only in support...
High-Fat Breakfast Increases Bioavailability of Albendazole Compared to Low-Fat Breakfast: Single-Dose Study in Healthy Subjects
Albendazole is a benzimidazole carbamate drug with anthelmintic and antiprotozoal activity against intestinal and tissue parasites. It has been described that the administration with meals increases albendazole absorption.
A novel in silico method to predict drug PK profile in human and its application to build the PBPK model of Hydroxychloroquine for COVID-19 treatment
The first part of this study is to develop a novel protocol to predict the pharmacokinetic profiles of a target drug based on the Physiologically based pharmacokinetic (PBPK) model of a structurally similar template drug by combining predictions from two software for PBPK modeling, the SimCYP simulator and ADMET Predictor.