Covariates are used to explain intra-individual variability of population parameters.
A randomized, double-blind, placebo-controlled phase 1b/2 study of ralimetinib, a p38 MAPK inhibitor, plus gemcitabine and carboplatin versus gemcitabine and carboplatin for women with recurrent platinum-sensitive ovarian cancer
This phase 1b/2 clinical trial (NCT01663857) evaluated the efficacy of ralimetinib in combination with gemcitabine (G) and carboplatin (C), followed by maintenance ralimetinib...
Synthesis and discovery of pyrazolo-pyridine analogs as inflammation medications through pro- and anti-inflammatory cytokine and COX-2 inhibition assessments
This article briefs about the efforts taken to synthesis, characterize and develop (E)-5-methyl-2-phenyl-3-(thiophen-2-yl)-7-(thiophen-2-ylmethylene)..
Peroxisome proliferator-activated receptor gamma controls prostate cancer cell growth through AR-dependent and independent mechanisms
Background: Prostate cancer (PC) remains a leading cause of cancer mortality and the most successful chemopreventative and treatment strategies for PC come from targeting...
Production of Lentiviral Vectors Using Suspension Cells Grown in Serum-free Media
Lentiviral vectors are increasingly utilized in cell and gene therapy applications because they efficiently transduce target cells such as hematopoietic stem cells and T cells. Large-scale production of current Good Manufacturing Practices-grade lentiviral vectors is limited because of the adherent, serum-dependent nature of HEK293T cells used in the manufacturing process.
Prediction of pH-Dependent Drug-Drug Interactions for Basic Drugs Using Physiologically Based Biopharmaceutics Modeling: Industry Case Studies
Acid-reducing agents (ARAs) such as antacids, histamine-2 receptor antagonists, and proton pump inhibitors are widely prescribed in several disease states.
Simulations Plus Partners with Large Pharmaceutical Company to Add New Capabilities to PKPlus
Funded customization project will enhance and simplify high-throughput processing of PK/TK datasets
Feature of the week #69: Sycomore
We know that development of a good model is a long process of incremental improvements.
GastroPlus® User Group Webinar: Physiologically Based Pharmacokinetic Modelling for First‑In‑Human Predictions
This webinar provides an overview of a recent publication on physiologically based pharmacokinetic (PBPK) modeling in first in human (FIH) predictions, and this was a collaborative effort from GastroPlus® User Group members.
A practical approach to modeling the impact of amorphous drug nanoparticles on the oral absorption of poorly soluble drugs
Recently published studies have proposed that amorphous drug nanoparticles in gastrointestinal fluids may be beneficial for the absorption of poorly soluble compounds.
Feature of the week #68: Scripting Monolix in R
Sometimes you might want to use Monolix through the interface but with scripts, for example to automate a set of actions in Monolix.
Simulations Plus Annual Forum “Partner with the Good Guys” at PharmSci 360
Thank you to everyone who joined us for the Simulations Plus, Inc. Annual Forum at American Association of Pharmaceutical Scientists (AAPS) Pharmsci360 in San Antonio, TX.
Prediction of the pharmacokinetics and pharmacodynamics of topiroxostat in humans by integrating the physiologically based pharmacokinetic model with the drug-target residence time model
Topiroxostat is a selective xanthine oxidoreductase (XOR) inhibitor for the management of hyperuricemia in patients with or without gout.
Simulations Plus Partners with Large Pharmaceutical Company to Enhance the Mechanistic Oral Absorption (ACAT) Model in GastroPlus
Funded collaborative research effort adds new functionality to the top-rated simulation engine.
Simulations Plus Reports FY2019 and Fourth Quarter FY2019 Financial Results
Full-Year Revenue Increased 14.5% to $34 Million
Duration of pretomanid/moxifloxacin/pyrazinamide therapy compared with standard therapy based on time-to-extinction mathematics
Animal models have suggested that the combination of pretomanid with pyrazinamide and moxifloxacin (PaMZ) may shorten TB therapy duration to 3–4 months.
Mechanistic Modelling of the Linkage Between Proximal Tubule Cell Sublethal Injury and Tubular Sodium Reabsorption Impairment
Sublethal renal epithelial cell injury, a key manifestation of drug-induced acute kidney injury (AKI), is characterized by loss of brush border and cellular polarity of proximal tubular cells (PTCs).
Evaluating the Nephrotoxicity of Exemplar Compounds Using a Mechanistic Model of Drug-Induced Acute Kidney Injury
Drug-induced nephrotoxicity is a common source of acute kidney injury (AKI) and a condition that complicates clinical outcomes of vulnerable patients.
Mechanistic Modeling Aids in the Interpretation of Alanine Aminotransferase Elevations Associated with Clinical Ischemic Liver Injury
DILIsym® software can use serial serum alanine aminotransferase (ALT) assessments to predict hepatocyte loss (HL) and corresponding changes in total bilirubin (TBIL) due to...