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.
Mathematical Modeling with NAFLDsym Supports the Role of Adiponectin in the Reduction of Steatosis by the Anti-FGFR1/KLB Bispecific Antibody
The agonist anti-FGFR1/KLB bispecific antibody, BFKB8488A, has been shown to be effective at reducing liver fat in NAFLD patients in a Ph1b study [1].
Structure-activity relationship, molecular docking, and molecular dynamic studies of diterpenes from marine natural products with anti-HIV activity
HIV-1 infection is a global epidemic whose treatment is limited majorly by viral resistance and adverse effects.
In Silico Modeling as a Tool to Predict and Characterize Plant Toxicity
One of the greatest challenges encountered during the manufacture of drugs is the high level of toxicity, which can have adverse effects on the environment, humans, plants, and animals.
Development of Quantitative Systems Toxicology Model to Predict Drug Induced Acute Kidney Injury via mtDNA Depletion Pathway
Treatment of chronic viral infections like HIV, Hepatitis B etc necessitates long term administration of powerful antivirals like...
Factors Affecting Successful Extrapolation of Ibuprofen Exposure from Adults to Pediatric Populations After Oral Administration of a Pediatric Aqueous Suspension
The importance of physiologically based pharmacokinetic (PBPK) model refinement with data acquired in adults using a pediatric...
Mechanistic Modeling of Cyclosporine A-induced Acute Kidney Injury with RENAsym®
The use of Cyclosporine A (CsA) can cause tubular damage leading to a decline in renal function as determined by decreases in serum creatinine levels...
Modeling Insights on Species Differences in Response to CD8+ T cell-mediated Liver Injury
Idiosyncratic drug-induced liver injury (iDILI), which is typically rare and often severe, has led to black box warnings or drug withdrawals from the market...
Advancing Calcitonin Gene-Related Peptide Receptor Antagonists Using Quantitative Systems Toxicology Modeling to Characterize Next-in-Class Compounds Compared to the Hepatotoxic First in Class Telcagepant
While CGRP receptor antagonists have demonstrated efficacy in the acute and preventive treatment of migraine...
Simulx – GUI: a flexible and user-friendly application for simulations
Advanced simulator of clinical trials and decision-making tool
Quantitative Systems Toxicology Modeling Supports Safety Determination for Ubrogepant, a Novel CGRP Inhibitor
CGRP inhibitors are a class of drugs that meet a significant unmet medical need for migraine treatments.
Representation of Efavirenz mediated Drug Induced Liver Injury (DILI) Using Quantitative Systems Toxicology (QST)
Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used in combination with other agents to treat human...