Conference Call to be on Thursday, April 9, 2020, at 4:15 PM ET
Feature of the week #84: VPC for time-to-event data
VPC of survival data is a crucial diagnostic plot in the modeling of time-to-event data
Simulations Plus Acquires Lixoft, Expanding Modeling Software Offerings and Broadening Presence in Europe
Accretive acquisition adds Monolix Suite, a population PKPD modeling solution for pharmacometricians
Translational Modeling Strategies for Orally Administered Drug Products: Academic, Industrial and Regulatory Perspectives
During non-clinical and clinical development of a new molecular entity (NME), modeling and simulation (M&S) are routinely used to predict...
Simulations Plus Sets Date for 2nd Quarter 2020 Earnings Release and Conference Call
Conference Call to be on Thursday, April 9, 2020, at 4:15 PM ET
A next generation risk assessment case study for coumarin in cosmetic products
Next Generation Risk Assessment (NGRA) is defined as an exposure-led, hypothesis-driven risk assessment approach that...
Physiologically-based pharmacokinetic models for children: Starting to reach maturation?
Developmental changes in children can affect the disposition and clinical effects of a drug, indicating that scaling an...
Alflutinib (AST2818), primarily metabolized by CYP3A4, is a potent CYP3A4 inducer
Alflutinib (AST2818) is a third-generation epidermal growth factor receptor (EGFR) inhibitor that inhibits both EGFR-sensitive mutations and T790M mutations.
Liver toxicity of anthraquinones: A combined in vitro cytotoxicity and in silico reverse dosimetry evaluation
Anthraquinones are found in a variety of consumer products such as dietary supplements, traditional Chinese medicines, and drugs.
(Q)SAR tools for the prediction of mutagenic properties: Are they ready for application in pesticide regulation?
The assessment of human health risks resulting from the presence of metabolites in groundwater and food residues has become an important element...
Feature of the week #83: Several ways to handle the baseline of PD models
The baseline of PD models can be estimated as a model parameter, fixed to the observed value or a mixture of both.
Simulations Plus Offers Rapid Response COVID-19 Research Initiative
New StrategiesPlus™ program created for collaborative research acceleration
Physiologically Based Biopharmaceutics Modeling and Virtual Bioequivalence Assessment to Support Formulation Development
Mechanistic Absorption and PK modeling using GastroPlus®
In vitro evaluation of reactive nature of E- and Z-guggulsterones and their metabolites in human liver microsomes using UHPLC-Orbitrap mass spectrometer
Guggulipid is known to be useful for hypercholesterolemia, arthritis, acne, and obesity.
Forced degradation studies of norepinephrine and epinephrine from dental anesthetics: Development of stability‐indicating HPLC method and in silico toxicity evaluation
Injectable solutions containing epinephrine (EPI) and norepinephrine (NE) are not stable, and their degradation is...
Feature of the week #82: Kaplan-Meier estimator
Have you ever wondered how the survival function is estimated from time-to-event data?
Sandra Suarez-Sharp Joins Simulations Plus to Lead Regulatory Strategies Team
Simulations Plus today announced the addition of Sandra Suarez-Sharp as Vice President, Regulatory Affairs to lead the new Regulatory Strategies team.
20-year FDA Master Reviewer will advise the planning of drug development programs with sponsor companies
Generalized PBPK Model for Evaluation of Inhalation Exposure of Volatile Organic Compounds
Physiologically based pharmacokinetic modeling (PBPK) is a valuable tool to evaluate inhalation exposure of volatile organic compounds (VOCs).
Quantitative Systems Toxicology (DILIsym) Modeling of the Acetaminophen Cellular Pathways for Liver Toxicity Supports that Acetaminophen is Not a Carcinogenic Hazard in Humans
Acetaminophen has a long history of safe use at therapeutic doses, but can cause liver injury at very high doses.