Some years ago, excipients were considered inert substances irrelevant in the absorption process. However, years of study have demonstrated that this belief is not always true.
Approaches of formulation bridging in support of orally administered drug product development
As a drug advances through the late stages of clinical development, formulation changes are common to meet clinical, manufacturing, and/or business needs.
Deciphering the immuno-pathological role of FLT, and evaluation of a novel dual inhibitor of topoisomerases and mutant-FLT3 for treating leukemia
Acute myeloid leukemia (AML) is a type of leukemia with an aggressive phenotype, that commonly occurs in adults and with disappointing treatment outcomes.
Simulations Plus and the University of Bath Awarded New FDA Grant
Project will focus on the development of a modeling & simulation framework to support an assessment of bioequivalence for locally-acting drugs in the gastrointestinal tract
Saliva Sampling in Therapeutic Drug Monitoring and Physiologically Based Pharmacokinetic Modeling: Review
Therapeutic drug monitoring investigations based on saliva samples can be utilized as an alternative to blood sampling for many advantages.
Use of Gastrointestinal Simulator, Mass Transport Analysis, and Absorption Simulation to Investigate the Impact of pH Modifiers in Mitigating Weakly Basic Drugs’ Performance Issues Related to Gastric pH: Palbociclib Case Study
It is well known that reduced gastric acidity, for example with concomitant administration of acid reducing agents, can result in variable pharmacokinetics and decreased...
Gustavo Mendes Lima Santos Joins the Simulations Plus Regulatory Fellowship
Ex-Anvisa General Manager will contribute to global regulatory strategies involving pharmacometrics
In vitro and in vivo evaluation of the main protease inhibitor FB2001 against SARS-CoV-2
FB2001 is a drug candidate that targets the main protease of SARS-CoV-2 via covalently binding to cysteine 145.
Predicting the correct dose in children: Role of computational Pediatric Physiological-based pharmacokinetics modeling tools
The pharmacokinetics (PKs) and safety of medications in particular groups can be predicted using the physiologically-based pharmacokinetic (PBPK) model.
First-in-human study to investigate the safety and pharmacokinetics of salvianolic acid A and pharmacokinetic simulation using a physiologically based pharmacokinetic model
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%)