The United States Food and Drug Administration guidelines for the bioequivalence (BE) testing of the generic drug products suggests that there should be an equal proportion of male and female population in the BE study.
Simulations Plus to Participate in 21st Annual Craig-Hallum Institutional Investor Conference
Simulations Plus to Participate in 21st Annual Craig-Hallum Institutional Investor Conference
Monolix Comparison Flyer
Your software should make it easier to conduct non-compartmental, bioequivalence and compartmental analysis and use that data to make the right decisions for your program.
Regulatory Strategies Flyer
Get to Market Faster with Robust Regulatory Strategies
Clinical Pharmacology & Pharmacometrics Software and Services Flyer
Supporting Dose Selection and Justification
Cheminformatics Software & Services Flyer
Understand Your Compound
PBPK Software and Services Flyer
Optimize Decision Making Throughout R&D with PBPK Predictions
Integrating Human Biomimetic Liver Microphysiology System with Quantitative Systems Toxicology Modeling to Predict DILI
Integrating Human Biomimetic Liver Microphysiology System with Quantitative Systems Toxicology Modeling to Predict DILI
Demystifying GPX™ Installation: Expert Insights and Practical Tips
Get ready to turbocharge your scientific team’s PBBM PBPK modeling technology with the latest version of GastroPlus®!
GPX™ The Next Level PBPK Platform
It’s here—the latest version of GastroPlus®, GPX. And this is your chance to see it in action.
Simulations Plus Releases GastroPlus® X, The Next Generation PBPK/PBBM Modeling & Simulation Software
Redesigned platform offers ease-of-use, enhanced software engineering, and significant productivity gains for users
Physiologically based absorption modeling to predict the bioequivalence of two apixaban formulations
The equivalence of absorption rates and extents between generic drugs and their reference formulations is crucial for ensuring therapeutic comparability.
GastroPlus®X (GPX™) Product Brochure
GastroPlus X (GPX™) is a mechanistically based simulation software package that simulates intravenous and oral absorption, pharmacokinetics, drug-drug interactions and pharmacodynamics in humans and animals.
GastroPlus®X Release Notes
Over the past several years, the Simulations Plus team has been revolutionizing oral small molecule PBPK/PBBM modeling with one of the most significant changes in the GastroPlus platform to date.
Women in Science: Nancy Lin, Pharmacometrician I
In a world where only 30% of researchers are female, it’s critical to highlight the women who have built their careers in STEM and share their insights and advice with others.
Advancing Toxicity Predictions: A Review on in Vitro to in Vivo Extrapolation in Next-Generation Risk Assessment
As a key step in next-generation risk assessment (NGRA), in vitro to in vivo extrapolation (IVIVE) aims to mobilize a mechanism-based understanding of toxicology to translate bioactive chemical concentrations obtained from in vitro assays to corresponding exposures likely to induce bioactivity in vivo.
In Vitro In Vivo Extrapolation and Bioequivalence Prediction for Immediate-Release Capsules of Cefadroxil Based on a Physiologically-Based Pharmacokinetic ACAT Model
Physiologically based pharmacokinetic (PBPK) modeling is a mechanistic concept, which helps to judge the effects of biopharmceutical properties of drug product such as in vitro dissolution on its pharmacokinetic and in vivo performance.
Assessing and mitigating pH-mediated DDI risks in drug development – formulation approaches and clinical considerations
pH-mediated drug-drug interactions (DDI) is a prevalent DDI in drug development, especially for weak base compounds with highly pH-dependent solubility.