Skin, being the largest organ of the body, represents an important route of exposure, not only for the abundance of chemicals present in the environment, but also for...
The Use of In Vitro and In Silico Technologies for Predicting Human Pharmacology and Toxicology of Carfentanil
Carfentanil is an ultra-potent opioid of public health and chemical weapons defense concern.
Integrating in vitro, modeling, and in vivo approaches to investigate warfarin bioequivalence
We demonstrate the use of modeling and simulation to investigate bioequivalence concerns raised about generic warfarin products.
Identification and characterisation of a salt form of Danirixin with reduced pharmacokinetic variability in patient populations
The natural variability of gastric pH or gastric acid reducing medications can result in lower and more variable clinical pharmacokinetics for basic compounds in patient populations.
Oral product input to the GI tract: GIS an oral product performance technology
The patient receives a pharmaceutical product, not a drug.
Calcium Phosphate Particles as Pulmonary Delivery System for Interferon-α in Mice
Systemically administered interferons are rapidly cleared from the circulation thus requiring frequent dosing to maintain the therapeutic levels of circulating interferon.
Using Quantitative Systems Toxicology (QST) to Assess Drug Safety: The Experience of the DILIsimInitiative. ®
Drug-Induced Liver Injury (DILI) remains a major problem in drug development.
Simulation of in vitro Dissolution and Degradation of Orntide-loaded PLGA Microspheres
An in vitro dissolution model has been developed to describe the drug release from orntide-loaded PLGA microspheres.
Utility of Physiologically Based Pharmacokinetic Absorption Modeling to Predict the Impact of Salt-to-Base Conversion on Prasugrel HCl Product Bioequivalence in the Presence of Proton Pump Inhibitors
Prasugrel HCl may convert to prasugrel base during manufacturing or storage. It was reported that formulations with different ratios of salt to base were bioequivalent in healthy subjects...
Prediction of Intracellular Exposure Bridges the Gap Between Target- and Cell-Based Drug Discovery
Inadequate target exposure is a major cause of high attrition in drug discovery. Here, we show that a label-free method for quantifying the intracellular bioavailability (Fic) of drug molecules…
Simulations Plus Sets Date for 3rd Quarter 2017 Earnings Release and Conference Call
Conference Call to be on Monday, July 10, 2017, at 4:15 PM ET
Simulations Plus Reports Third Quarter FY2017 Financial Results
Record quarter as revenues grow 12.2%, 9MoFY17 net income up 11.4%
Synthesis and pharmacodynamics of ibuprofen-1-acetoxyethyl ester
Ibuprofen(IBU) and its derivatives are widely used in treating many diseases, such as depression, glomerulonephritis, fever caused by common cold or influenza, and rheumatoid arthritis.
In vitro–in vivo and pharmacokinetic evaluation of solid lipid nanoparticles of furosemide using Gastroplus™
In this work, we conducted pharmacokinetic studies and established the in vitro and in vivo correlation (IVIVC) of furosemide (FRS) loaded solid lipid nanoparticles (FSLN).
Prediction of efficacy for conversion from adjunctive therapy to monotherapy with eslicarbazepine acetate 800 mg once daily for partial-onset epilepsy.
Eslicarbazepine acetate (ESL) is a once-daily (QD) oral antiepileptic drug (AED) indicated for partial-onset seizures (POS). Clinical studies of gradual conversion to ESL 1,200 and 1,600 mg QD...
Applications of Mechanistic Modeling and Simulations in Compound and Dosage Forms Selections
Physiologically based pharmacokinetic (PBPK) modeling and simulation techniques have been adopted in the pharmaceutical industry to aid in compound selection and dosage form development in recent years.