In this study, Caco-2 permeability results from different laboratories were compared. Six different sets of apparent permeability coefficient (Papp) values reported in the literature were...
Mechanistic investigation of the negative food effect of modified release zolpidem
When administered orally as either an immediate or modified release dosage form, zolpidem demonstrates a negative foodeffect, i.e. decrease in Cmax and AUC.
Exploring Canine – Human Differences in Product Performance. Part II: Use of Modeling and Simulation to Explore the Impact of Formulation on Ciprofloxacin In Vivo Absorption and Dissolution in Dogs
This study explored the in vivo performance of three oral ciprofloxacin formulations (oral solution, fast, or slow dissolving tablets) in beagle dogs.
The impact of supersaturation level for oral absorption of BCS class IIb drugs, dipyridamole and ketoconazole, using in vivo predictive dissolution system: Gastrointestinal Simulator (GIS)
The development of formulations and the assessment of oral drug absorption for Biopharmaceutical Classification System (BCS) class IIb drugs is often a difficult issue due to the potential for...
Dr. Daniel Weiner Joins Simulations Plus Board of Directors
World-renowned scientist, FDA consultant, and experienced manager to reinforce SLP board
Simulations Plus to Acquire DILIsym Services, Inc.
Accretive acquisition to expand Simulations Plus offerings by adding leading provider of drug-induced liver injury (DILI) software and consulting services
Physiologically Based and Population Pharmacokinetic (PBPK, PPK) Modeling and Simulation to Support Dose Selection and Study Design for Eslicarbazepine Acetate (ESL) Adjunctive Therapy in Infants with Partial-Onset Seizures (POS)
Eslicarbazepine acetate (ESL) is a once-daily (QD) oral antiepileptic drug (AED), approved as adjunctive treatment in adults ≥18 years for partial-onset seizures (POS) in the USA and Canada, and as...
Modeling and Simulation Strategy to Support Eslicarbazepine Acetate (ESL) Pediatric Dose Selection in the Treatment of Partial-Onset Seizures (POS) Based on Matching Adult Exposures
Eslicarbazepine acetate (ESL) is a once-daily (QD) oral antiepileptic drug (AED), approved as adjunctive treatment in adults > years for partial-onset seizures (POS) in the USA and Canada, and as monotherapy...
Studies on Core-Shell Nanocapsules of Felodipine: In Vitro-In Vivo Evaluations
The present study aimed for in vitro-in vivo-in silico simulation studies of experimentally designed (32-factorial) Capmul PG-8-cored, Eudragit RSPO-Lutrol F 127 nanocapsules to ferry felodipine using GastroPlus™.
Identification of novel TACE inhibitors compatible with topical application
Targeting the Tumor Necrosis Factor α signalling with antibodies has led to a revolution in the treatment of psoriasis. Locally inhibiting Tumor Necrosis Factor α Converting Enzyme...
Evolution of Circulating Tumor DNA Profile from First-line to Subsequent Therapy in Metastatic Renal Cell Carcinoma
Background: Treatment of metastatic renal cell carcinoma (mRCC) typically entails mechanistically distinct agents across the first- and second-line setting.
Prediction of Losartan Active Carboxylic Acid Metabolite Exposure Following Losartan Administration Using Static and Physiologically-Based Pharmacokinetic Models.
The aim of this study was to evaluate a strategy based on static and dynamic physiologically based pharmacokinetic (PBPK) modeling for the prediction of metabolite and parent drug area under...
Development and qualification of physiologically based pharmacokinetic models for drugs with atypical distribution behavior: A desipramine case study.
Desipramine is a secondary tricyclic amine, which is primarily metabolized by cytochrome 2D6. It shows a high volume of distribution (Vss) (10–50 L/kg) due to its high lipophilicity, unspecific phospholipid binding, and lysosomal trapping.
Modeling of Active Transport and Metabolism for in vitro Suspended and Sandwich Hepatocyte Assays Utilizing MembranePlus
MembranePlus™ – a software platform for simulaton of drug transport in cell assays.
Simulations Plus Reports Second Quarter FY2017 Financial Results
Record second quarter as revenues grow 10.5%, 6MoFY17 net income up 13.6%