Salvianolic acid A (SAA) is a water-soluble phenolic acid component from Salvia miltiorrhiza Bunge currently under development for myocardial protection treatment for coronary heart disease (CHD).
What is QST/QSP Modeling?
With more than 20 years of industry experience, Chief Science Officer of DILIsym Services, Scott Q. Siler describes it this way, “think of modeling like photography.”
Simulations Plus 25th Anniversary Celebration Concludes with $25,000 Gift to Nonprofit, Girls Who Code
International organization’s mission is to close the gender gap in technology
Formulation of metoclopramide HCl gastroretentive film and in vitro- in silico prediction using Gastroplus® PBPK software
The new trends in pharmaceutical studies focus on targeting drug delivery and computer software that help in the body environment simulation, such as Gastroplus® software.
Simulations Plus and the University of Florida Awarded New FDA Contract to Support Development and Regulatory Assessment of Inhaled Products
Collaboration combines novel in vitro experimental methods and mechanistic modeling to accelerate development of orally inhaled drug products (OIDPs) and propose alternative approaches for bioequivalence
Evaluation of a Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union
Bioequivalence (BE) of products containing narrow therapeutic index (NTI) drugs in theEuropean Union is currently established by demonstrating that the 90% confidence interval for theratio of the population geometric...
Inferring Therapeutic Targets in Candida albicans and Possible Inhibition through Natural Products: A Binding and Physiological Based Pharmacokinetics Snapshot
Despite being responsible for invasive infections, fungal pathogens have been underrepresented in computer aided therapeutic target mining and drug design.
Development of physiologically based pharmacokinetics model for prediction of drug disposition in diabetic patients
Background: There is growing evidence that diabetes mellitus modifies the pharmacokinetics of several medications, changing their pharmacodynamics.
A physiologically based pharmacokinetic model for open acid and lactone forms of atorvastatin and metabolites to assess the drug-gene interaction with SLCO1B1 polymorphisms
Atorvastatin is the most prescribed 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor used to lower cardiovascular risk and constitutes one of the best-selling drugs world-wide.
Simulations Plus Reports Fourth Quarter and Full Fiscal Year 2022 Financial Results
Fiscal 2022 revenue increased 16% year-over-year to $53.9 million
Diluted earnings per share increased 28% year-over-year to $0.60
Provides Fiscal 2023 guidance for total revenue of $59.3 million to $62.0 million (+10% to 15%)
Absorption, distribution, metabolism, and excretion of [14C]Mefuparib (CVL218), a novel PARP1/2 inhibitor, in rats
Mefuparib (CVL218) is a novel second-generation poly-ADP-ribose polymerase (PARP) inhibitor for cancer treatment.
Physiologically based pharmacokinetic modeling and simulation of cannabinoids in human plasma and tissues
There has been an increased public interest in developing consumer products containing nonintoxicating cannabinoids, such as cannabidiol (CBD) and cannabigerol (CBG).
Simulations Plus Announces Cash Dividend
Board of Directors announces quarterly dividend of $0.06 per share
Physiologically Based Pharmacokinetic (PBPK) Modeling of Rifampicin and Its Application for Drug-Drug Interaction with Midazolam in Adults
Rifampicin (RIF) is an essential part of tuberculosis therapy and the pharmacokinetics (PK) of RIF has been of interest due to its non-linear and auto-induction behavior
Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Gatifloxacin Solution Case Study
Development of generic ophthalmic drugs has been extremely challenging due to the complexity of the ocular system and a lack of sensitive testing tools to evaluate its interplay with ophthalmic formulations.
Application of Modeling and Simulation in Long-Acting Injectable Product Development
Discuss advances in mechanistic models to simulate in vitro and in vivobehavior of long acting injectables.
From Preclinical to Clinical Drug Product Development: A Path for Smooth Transition
It is challenging to establish a standard approach for moving from preclinical to clinical phases of development. Many hurdles exist during formulation selection and for extrapolation of doses from animals to humans; what may have worked well for one drug candidate may not be appropriate for others. This presentation will provide a general framework/strategy to follow when moving from preclinical to clinical studies (FIH) based on risk identification and mitigation focusing on the application of mechanistic modeling and simulation (PBPK).