The world is constantly changing, and with the advancement of technology, it is moving at an accelerated pace.
In Silico Modeling and Simulation to Guide Bioequivalence Testing for Oral Drugs in a Virtual Population
Model-informed drug discovery and development (MID3) shows great advantages...
Population Pharmacokinetics (Pop PK) of MYL‑1402O (a Proposed Biosimilar to Bevacizumab) and Reference Product (Avastin) in Patients With Nonsquamous Non-Small Cell Lung Cancer (nsNSCLC)
MYL-1402O (MYL) is a proposed biosimilar to bevacizumab reference product. A multicenter, double blind randomized, phase 3 study compared the efficacy, safety, PK, and immunogenicity of...
Treatment Optimization of Maintenance Immunosuppressive Agents in Pediatric Renal Transplant Recipients
Introduction: Graft survival in pediatric kidney transplant patients has increased significantly within the last three decades, correlating with the discovery and utilization of new immunosuppressants as well as...
Experimental Solubility of Ketoconazole, Validation Models, and In vivo Prediction in Human Based on GastroPlus
The study aimed to identify a suitable cosolvent + water mixture for subcutaneous...
Simulations Plus Sets Date for Third Quarter Fiscal Year 2021 Earnings Release and Conference Call
Conference call to be on Monday, July 12, 2021, at 4:15 p.m. ET
Beta-thalassemia major alters sofosbuvir/ledipasvir exposure in Hepatitis C virus infected adolescent patients
Hepatitis C virus (HCV) infected adolescents with beta-thalassemia major (BTM) are considered a potential population for HCV micro-elimination model development where BTM may...
A physiologically-based nanocarrier biopharmaceutics model to reverse-engineer the in vivo drug release
Over the years, a wide variety of nanomedicines has entered global markets, providing a blueprint for the emerging generics industry.
PBPK Modeling Approach to Predict the Behavior of Drugs Cleared by Kidney in Pregnant Subjects and Fetus
The purpose of this study was to develop a physiologically based pharmacokinetic (PBPK) model predicting the pharmacokinetics (PK) of different compounds in pregnant subjects.
Introducing, IPFsym™ the QSP modeling software for idiopathic pulmonary fibrosis
IPFsym® is a mechanistic, mathematical model for QSP of idiopathic pulmonary fibrosis (IPF) that can be used to predict efficacy for potential treatments.
Application of a dual mechanistic approach to support bilastine dose selection for older adults
The objective of this study was to evaluate bilastine dosing recommendations in older adults and overcome the limitation of insufficient data from phase I studies in this underrepresented population.
Use of Physiologically Based Pharmacokinetic Modeling for Predicting Drug–Food Interactions: Recommendations for Improving Predictive Performance of Low Confidence Food Effect Models
Food can alter drug absorption and impact safety and efficacy.
Quantitative Systems Pharmacology Modeling of Fibrotic Diseases
NAFLDsym Is Designed to Support Drug Development with Efficacy Predictions
Culture & Conversation – The accelerator pedal for innovation…
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.