Acetaminophen has a long history of safe use at therapeutic doses, but can cause liver injury at very high doses
Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model‐Based Bioequivalence
On May 4, 2020, the US Food and Drug Administration (FDA) hosted an online public workshop titled “FY 2020 Generic Drug Regulatory Science...
In vitro investigation of metabolic fate of α-mangostin and gartanin via skin permeation by LC-MS/MS and in silico evaluation of the metabolites by ADMET predictor™
Mangosteen, Garciniam angostana L., is a juicy fruit commonly found in Thailand.
A Novel Eutectic-Based Transdermal Delivery System for Risperidone
This paper reports for the first time the possible formation of a novel room temperature therapeutic deep eutectic solvent (THEDES)...
Novel substituted N-benzyl(oxotriazinoindole) inhibitors of aldose reductase exploiting ALR2 unoccupied interactive pocket
Recently we have developed novel oxotriazinoindole inhibitors (OTIs) of aldose reductase (ALR2), characterized by high efficacy and selectivity.
Managing the challenge of drug-induced liver injury: a roadmap for the development and deployment of preclinical predictive models
Drug-induced liver injury (DILI) is a patient-specific, temporal, multifactorial pathophysiological process that cannot yet be recapitulated in a single in vitro model.
Statement from Cognigen’s President, Jill Fiedler-Kelly
At Cognigen, we appreciate more than ever, the global community in which we live and work and the impact each of us can...
Metabolic Profiling of Nuciferine In Vivo and In Vitro
Nuciferine (NF) is one of the main constituents of Lotus (Nelumbo nucifera) leaves which have been widely used in both food and drug formulations in China.
Solubility and Stability Enhanced Oral Formulations for the Anti-Infective Corallopyronin A
Novel-antibiotics are urgently needed to combat an increase in morbidity and mortality due to resistant bacteria.
Relevance of Physiologically Based Biopharmaceutical Modeling (PBBM) in the Approval of Generic Products
The Webinar "Relevance of Physiologically Based Biopharmaceutical Modeling (PBBM) in the Approval of Generic Products", which will be presented in Spanish
Dose Optimization in Kidney Disease: Opportunities for PBPK Modeling and Simulation
Kidney disease affects pharmacokinetic (PK) profiles of not only renally cleared drugs but also nonrenally cleared drugs.
Model‐Informed Dose Optimization in Pregnancy
Pregnancy is associated with several physiological changes that can alter the pharmacokinetics (PK) and pharmacodynamics of drugs.
Simulations Plus Reports Fourth Quarter FY2020 Financial Results
Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today reported financial results for its 2020 fiscal year (FY20) and fourth quarter (4QFY20) ended August 31, 2020.
Novel Clinical Trial Designs for Optimizing Parameter Estimation in Malaria Disease-Drug Models
An introduction to Model-Informed Drug Development (MIDD) for Malaria and Volunteer Infection Studies (VIS)
Principles of Ensuring Data Integrity
Have you ever lost data or have someone who worked on a project leave and take their knowledge of the data with them? Stream the webinar replay by Dr. Joel Owen in collaboration with Pharmacometrics Africa.
StrategiesPlus™ COVID-19 ACT Program
According to the World Health Organization (WHO), COVID-19 has infected more than 5.45 million patients and killed more than 1.25 million people worldwide as of November 10, 2020.
Assessment of the Mechanism for Remdesivir-Associated Clinical ALT Elevations Using DILIsym Quantitative Systems Toxicology Modeling
Remdesivir, a monophosphoramidate prodrug of a nucleoside analog, has been granted Emergency Use Authorization in the U.S. for the treatment of hospitalized COVID-19 patients.