To fit an absorption-pharmacokinetic model for simulation of Gabapentin in adult and pediatric populations. The model will be able to describe the nonlinear dose dependence of absorption mediated by an amino…
GlaxoSmithKline Renews and Expands Global License for Simulations Plus Software
Company Adds Parsippany, NJ Site to Multi-year Agreement
Simulations Plus Reports Second Quarter and Six Months FY2008 Financial Results
Revenues Up 4.3%, and Earnings Up 9.0% for First 6 Months of FY2008
Simulations Plus Sets Date for Second Quarter Earnings Release and Conference Call
Conference Call to Be on Tuesday, April 15, at 4:15 PM EDT
U.S. FDA Renews and Expands GastroPlus(TM) Software License
Adds New ADMET Predictor(TM) Module
Simulations Plus’ Software Selected Application of Choice by Premier Pharmaceutical Company
Top 3 Company Adds Software Licenses to Multi-year Agreement
Population Pharmacokinetics of Bendamustine and Metabolites in Patients With Indolent Non-Hodgkin Lymphoma
Bendamustine is a bifunctional alkylating agent in development as monotherapy and in combination with other agents in the treatment of indolent non-Hodgkin lymphoma (NHL).
Model Feasibility Assessment as a Driver for Model-Based Drug Development
Complex pharmacometric analyses raise concerns about cost, time, and reliability of the modelbuilding process (MBP). The goal was to use a model feasibility assessment (MFA) process to improve the performance…
Simulations Plus Releases Major Upgrade to ADMET Predictor™ Software
Version 2.4 Adds Industry’s First Metabolism Kinetics Module for Key Enzymes
Application of Gastrointestinal Simulation for Extensions for Biowaivers of Highly Permeable Compounds
The goal of this study was to apply gastrointestinal simulation technology and integration of physiological parameters to predict biopharmaceutical drug classification.
The effect of age, gender, and body mass index on the pharmacokinetics and pharmacodynamics of vildagliptin in healthy volunteers
What is already known about this subject. Vildagliptin is a new, potent, and selective inhibitor of DPP-4. The efficacy and safety of vildagliptin in type 2 diabetes has been...
Drug Lipophilicity and Microsomal Protein Concentration as Determinants in the Prediction of the Fraction Unbound in Microsomal Incubations
The current study was undertaken to elucidate the relative utility of these prediction tools over a range of drug lipophilicity and microsomal protein concentration.
Novel Hierarchical Classification and Visualization Method for Multiobjective Optimization of Drug Properties: Application to Structure-Activity Relationship Analysis of Cytochrome P450 Metabolism
In the lead optimization process, medicinal chemists must consider various chemical properties of active compounds, including ADME/Tox properties, and find the best compromise among these.
Simulations Plus Reports First Quarter FY2008 Financial Results
Revenues Increase 36%, Earnings Increase 232%
A critical evaluation of fasted state simulating gastric fluid (FaSSGF) that contains sodium lauryl sulfate and proposal of a modified recipe.
The aim of this work is to evaluate one of the most commonly used fasted state simulating gastric fluids (FaSSGFs), which contains sodium lauryl sulfate (SLS) (FaSSGFSLS), and propose a more appropriate...
Exposure response analyses of tigecycline efficacy in patients with complicated intra-abdominal infections
Exposure-response analyses were performed to test the microbiological and clinical efficacies of tigecycline in complicated intra-abdominal infections where...
Design and implementation of cell-based assays to model human disease
Cell-based assays, if appropriately designed, can be used to rapidly identify molecular mechanisms of human disease and develop novel therapeutics. In the last 20 years...
PK/PD Modeling of Adinazolam
Develop a model for prediction of the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of Adinazolam from IV, immediate release oral, and controlled release oral formulations.
Influence Of Estimation Of Inter-Occasion Variability On Detection Of Time-Varying Covariates
To explore the influence of the estimation of inter-occasion variability (IOV) on the ability to detect time-varying covariates influencing PK parameters from a population PK (PPK) analysis using NONMEM.