Modeling and simulation of drug dissolution and oral absorption has been increasingly used over the last decade to understand drug behavior in vivo based on the physicochemical properties of Active...
Preclinical Assessment of the Absorption and Disposition of the Phosphatidylinositol 3-Kinase/Mammalian Target of Rapamycin Inhibitor GDC-0980 and Prediction of Its Pharmacokinetics and Efficacy in Human
The objectives of these studies were to characterize the absorption and disposition of GDC-0980 and assess its efficacy in an MCF7-neo/HER2 human breast cancer xenograft model in immunocompromised mice.
Application of PBPK modeling to predict human intestinal metabolism of CYP3A substrates – An evaluation and case study using GastroPlus™
First pass metabolism in the intestinal mucosa is a determinant of oral bioavailability of CYP3A substrates and so the prediction of intestinal availability (Fg) of potential drug candidates is important.
Comparison of in vitro–in vivo release of Risperdal® Consta® microspheres
The objective was to investigate the relationship between in vitro and in vivo release of commercial Risperdal® Consta® microspheres.
Regioselective oxidation of phospho-NSAIDs by human cytochrome P450 and flavin monooxygenase isoforms: implications for their pharmacokinetic properties and safety
Phospho-ibuprofen (MDC-917) and phospho-sulindac (OXT-328) are highly effective in cancer and arthritis treatment in preclinical models. Here, we investigated their metabolism by...
Predicting feasibility and characterizing performance of extended-release formulations using physiologically based pharmacokinetic modeling
This review presents nine case studies where physiologically based pharmacokinetic modeling has been used in the design and development of extended-release formulations.
Enhanced evaluation of selective androgen receptor modulators in vivo
Selective androgen receptor modulators (SARMs) are a class of drugs that control the activity of the androgen receptor (AR), which mediates the response to androgens, in a...
An analysis of N-acetylcysteine treatment for acetaminophen overdose using a systems model of drug-induced liver injury
N-acetylcysteine (NAC) is the treatment of choice for acetaminophen poisoning; standard 72-h oral or 21-h intravenous protocols are most frequently used.
Human apolipoprotein E peptides inhibit hepatitis C virus entry by blocking virus binding
Hepatitis C virus (HCV) entry is a multiple-step process involving a number of host factors and hence represents a promising target for new antiviral drug development.
Translation of drug effects from experimental models of neuropathic pain and analgesia to humans
Neuropathic pain research remains a challenging undertaking owing to: (i) the lack of understanding about the underlying disease processes; and (ii) poor...
Prediction of acute mammalian toxicity using QSAR methods: a case study of sulfur mustard and its breakdown products
Predicting toxicity quantitatively, using Quantitative Structure Activity Relationships (QSAR), has matured over recent years to the point that the predictions can be used to help identify missing comparison...
Simulations Plus Announces Next Quarterly Cash Dividend
Company declares cash dividend of $0.05 per share
Developing In Vitro–In Vivo Correlation of Risperidone Immediate Release Tablet
The present study was aimed to predict the absorption profile of a risperidone immediate release tablet (IR) and to develop the level A in vitro–in vivo correlation (IVIVC) of the drug using...
In silico prediction of drug dissolution and absorption with variation in intestinal pH for BCS class II weak acid drugs: ibuprofen and ketoprofen
The FDA Biopharmaceutical Classification System guidance allows waivers for in vivobioavailability and bioequivalence studies for immediate-release solid oral...
Simulations Plus Reports 3rd Quarter and First 9 Months FY2012 Financial Results
3rd quarter sales increase 5.0% to $2.77 million; 9 months net income up 5.9% to $2.68 million
Simulations Plus Sets Date for 3rd Quarter 2012 Earnings Release and Conference Call
Conference Call to Be on Thursday, July 12, at 4:15 PM ET
Simulations Plus Expands Marketing and Sales Staff
Ms. Anu Sharma Joins the Company as Senior Sales and Marketing Manager, focusing on Cheminformatics Products
Ethanol Effects on Apparent Solubility of Poorly Soluble Drugs in Simulated Intestinal Fluid
Ethanol intake can lead to an unexpected and possibly problematic increase in the bioavailability of druglike compounds. In this work we investigated the effect of ethanol on the apparent solubility...
Computational Prediction of CNS Drug Exposure Based on a Novel In Vivo Dataset
To develop a computational model for predicting CNS drug exposure using a novel in vivo dataset.