Better tools and processes can improve the efficiency of data assembly and the quality of analysis-ready datasets for pharmacometric analyses.
Modeling and Simulation Approach to Pediatric Drug Development
Describe a process for determining pediatric drug doses using pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation.
Prediction of Dose-Dependent Intestinal and Liver First Pass Extraction for CYP3A4 Substrates
Cilostazol and midazolam absorption and pharmacokinetics were simulated using GastroPlus™. The program’s Advanced Compartmental and Transit model described the absorption and intestinal metabolism of both…
Simulations Plus Reports Preliminary Results for Third Fiscal Quarter
Company CEO to Present at New York City Investor Meeting and Webinar
Role of physiological intestinal water in oral absorption
Water volume has impact when the compound has low aqueous solubility. For example, the absorption of compounds with a Biopharmaceutics Classification System...
Prediction of modified release pharmacokinetics and pharmacodynamics from in vitro, immediate release, and intravenous data
The aim of this study was to demonstrate the value of mechanistic simulations in gaining insight into the behaviors of modified release (MR) formulations in vivo and...
Simulations of the nonlinear dose dependence for substrates of influx and efflux transporters in the human intestine
The purpose of this study was to develop simulation and modeling methods for the evaluation of pharmacokinetics when intestinal influx and efflux transporters are involved...
An investigation into the importance of “Very Rapid Dissolution” criteria for drug bioequivalence demonstration using gastrointestinal simulation technology
The Biopharmaceutics Classification System (BCS) is based on the mechanistic assumptions that the rate and extent of oral drug absorption are governed by drug solubility...
Physiologically-Based Model for Fluvoxamine Disposition and Prediction of Drug-Drug Interactions
Fluvoxamine absorption and pharmacokinetics were simulated using GastroPlus™. The program’s Advanced Compartmental and Transit model described the absorption; pharmacokinetics was simulated with a…
Prediction of drug -drug interactions for fluconazole using PBPK – a case with concentration-dependent liver:plasma partition coefficient
Fluconazole is an antifungal agent widely used in the clinical setting for the treatment of candidiasis and meningitis. It undergoes minimal metabolism and is excreted renally(1). Fluconazole is a moderate…
Timing and incidence of postoperative infections associated with blood transfusions: analysis of 1,489 orthopedic and cardiac surgery patients
Transfusion rates remain high in cardiac and orthopedic surgery and differ widely across physician practices in spite of growing knowledge that allogeneic...
Simulations Plus Announces Change In Acquisition Status
One Pharmaceutical Acquisition Declined, Others Under Investigation
Simulations Plus Appoints Michael Pelekis, PH.D., Director for Business Development
New Position To Focus On Acquisitions And Collaborations
Modeling Drug Disposition in Ocular Tissues following Topical Eye Drops and Intravitreal Injection
The purpose of this study was to model the ocular absorption, distribution and clearance of clonidine and voriconazole from topical and intravitreal applications, respectively. Clonidine is a potent…
Computer simulations using GastroPlus to justify a biowaiver for etoricoxib solid oral drug products
The purpose of this study was to compare the dissolution behaviour of etoricoxib in different dissolution media and to establish in vitro/in vivo correlation (IVIVC) using computer simulations.
Simulations Plus Wins Phase II, Small Business Innovation Research Grant
$525,000 Grant to Speed Commercialization of Advancements to Company’s Industry-Leading Molecular Property Prediction Software
Simulations Plus Reports Second Quarter FY2009 Financial Results
Continued Growth – Revenues Up 12.7%, Cash Up 20.2%
Simulations Plus Sets Date for Second Quarter Fiscal Year 2009 Earnings Release and Conference Call
Conference Call to be on Wednesday, April 15, at 4:15 PM EDT
Non-competitive androgen receptor inhibition in vitro and in vivo
Androgen receptor (AR) inhibitors are used to treat multiple human diseases, including hirsutism, benign prostatic hypertrophy, and prostate cancer, but all available...