Dementia-related psychosis impacts more than 2.4 million patients;1-5 however, there are no
Population pharmacokinetics of MYL-1401O (a trastuzumab biosimilar) and reference trastuzumab (Herceptin®) in patients with HER2-positive metastatic breast cancer
Mylan trastuzumab (MYL-1401O) is a biosimilar to trastuzumab (Herceptin®)
Quantitative systems toxicology (DILIsym) modeling of the acetaminophen (paracetamol) mode of action (MOA) pathway for hepatotoxicity 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
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].
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...
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...
Mathematically modeling CD8+ T cell-mediated drug induced liver injury (DILI): from ovalbumin to amodiaquine in mice
Idiosyncratic drug-induced liver injury (iDILI) is poorlynunderstood, but there is evidence to support that some iDILI events may be immune-mediated.
Simulation of first-in-human using an allometrically scaled population mechanistic TMDD model with preclinical monkey data
First-in-human: what dose to choose to elicit the desired effect (efficacy), without causing harm (safety)?
Implementation of the C-QTc study using MonolixSuite applications
International Council for Harmonisation (ICH) E14 guidance agreed to use a model-based study of concentration-QT data as a primary analysis in...
A library of tumor growth and tumor growth inhibition models for the MonolixSuite
Modular tumor growth (TG) and tumor growth inhibition (TGI) library
Comparison of pharmacokinetics and QTc effect of Quizartinib in Japanese and non-Japanese patients with Relapsed/Refractory (R/R) FLT3-ITD positive acute myeloid leukemia (AML) using population pharmacokinetic (PopPK) analyses
The PopPK and C-QTc analyses were conducted to compare the pharmacokinetic (PK) profiles and QTc effect of quizartinib in Japanese...
Quantitative Prediction of Cisplatin-Induced Acute Kidney Injury Using RENAsym, a Mechanistic Quantitative Systems Toxicology Model, and Renal Proximal Tubule Epithelial Cell In vitro Assays
Nephrotoxic drugs like cisplatin cause acute kidney injury (AKI) through complex cellular mechanisms that include mitochondrial dysfunction...
Quantitative Systems Toxicology Modeling Using DILIsym Suggests That Drug-Induced Liver Injury Can Be Enhanced by Co-administered Drugs and Mitigated by Mitochondrial Biogenesis
Drug-induced liver injury (DILI) can be enhanced by polypharmacy if co-administered drugs induce toxicity via mechanisms that have overlapping pathways.
Exposure-Response Modeling From the CLARITY Trial of Pimavanserin for Adjunctive Treatment of Major Depressive Disorder
Pimavanserin displays selective inverse agonist and antagonist activity at 5-hydroxytryptamine-2A (5-HT2A) receptors with lesser activity at 5-HT2C receptors, and no appreciable activity at adrenergic, dopaminergic, histaminergic, or muscarinic receptors.