The central idea behind the “learn and confirm” paradigm is to emphasize the learning part of R&D and then intelligently apply what has been learned to the design of clinical trials.
RENAsym, a QST Model to Predict Drug-Induced Kidney Injury
Drug-induced kidney injury or acute kidney injury (AKI) is one of the major reasons for drug failure behind cardiovascular and liver injuries
Simulations Plus Releases IPFsym version 1A, State-of-the-Art Quantitative Systems Pharmacology (QSP) Software for Idiopathic Pulmonary Fibrosis (IPF)
IPFsym will enable new software and services revenue by aiding development of IPF therapies
Mathematical Modeling in Industry: Building Models to Advance Drug Development
QSP models are designed to characterize biological systems, representing details such as disease pathophysiology, drug pharmacology, and pathways of toxicity
Quantifying Exposure is the Foundation of Pharmacometric Analysis
Kevin Dykstra answers questions like, "Why do we care about Drug Exposure?"
Best Practices for Membrane & Biphasic In Vitro Dissolution with DDDPlus™ & GastroPlus®
DDDPlus is a state-of-the-art simulation platform for in vitro dissolution.
Training and Education – Learning tomorrow’s science… today.
As I think back on 20+ years of lecturing on the population modeling & simulation (M&S) approach, I am simultaneously struck by how much has changed and how much has remained the same.
Ensuring the Quality and Accuracy of Analysis-Ready Datasets
Our experience in data assembly is extensive: we’ve been building analysis-ready datasets for pharmacometric modeling and simulation for over 25 years.
June 2021 GastroPlus Newsletter
A long time ago, in a desert far, far away…
Development, validation and application of physiologically based biopharmaceutics model to justify the change in dissolution specifications for DRL ABC extended release tablets
The generic drug product DRL ABC is an Extended Release (ER) Tablet manufactured by Dr. Reddy’s Laboratories Limited and have multi point dissolution as part of release specification.
Meta-Assessment of Metformin Absorption and Disposition Pharmacokinetics in Nine Species
The objective of this study was to systematically assess literature datasets and quantitatively analyze metformin PK in plasma and some tissues of nine species.
Simulation of Remdesivir Pharmacokinetics and Its Drug Interactions
Remdesivir, a drug originally developed against Ebola virus, is currently recommended for patients hospitalized with coronavirus disease of 2019 (COVID-19).
Relationship Between Pimavanserin Exposure and Negative Symptoms in Patients With Schizophrenia: Data Analysis From the Phase 2 ADVANCE Study
Negative symptoms in schizophrenia are associated with poor psychosocial function and long-term outcomes yet no pharmacological treatments are currently approved in the United States to treat...
Application of physiologically based biopharmaceutics modeling (PBBM) to understand the impact of dissolution differences on in vivo performance of immediate release products: The case of bisoprolol
Merck KGaA observed slight differences in the dissolution of Concor® (bisoprolol) batches over the years.
Oral APX3330 treatment reduces L-CNV lesions in preclinical mouse model and confirms Phase 2 DR/DME clinical dose with sufficient distribution to human retina using PBPK modeling
APX3330 is a small molecule inhibitor of Ref-1, a target involved in key vascular and inflammatory ocular disease processes including diabetic retinopathy (DR), diabetic macular edema (DME) and wetAMD.
Particle Deposition in Respiratory Tract: Where are the Limits?
In last two decades in silico biopharmaceutics modelling has become increasingly important in all stages of drug development.
Simulations Plus to Participate in 18th Annual Craig-Hallum Institutional Investor Conference
Simulations Plus to Participate in 18th Annual Craig-Hallum Institutional Investor Conference
Installing ADMET Predictor on Linux OS
Installation instructions for ADMET Predictor® using Linux OS