Patients with schizophrenia who are receiving more than one antipsychotic may be at higher risk for QT interval...
Pharmacokinetic Profile of Pimavanserin in Patients With Dementia-Related Psychosis and Concomitant Acetylcholinesterase Inhibitor Use: Modeling Data From the Phase 3 HARMONY Study
Pimavanserin is a selective serotonin-modulating agent with inverse agonist/antagonist activity at the 5HT2A receptor, and to a lesser extent at...
Model-based dose selection for the phase 3 evaluation of molnupiravir (MOV) in the treatment of COVID-19 in adults
There is an urgent need for effective treatment options that are easily administered and readily implementable in health systems globally to reduce the impact of COVID-191
Relationship Between Pimavanserin Exposure and Negative Symptoms in Patients With Schizophrenia: Data Analysis From the Phase 2 ADVANCE Study
Negative symptoms in schizophrenia are associated with poor psychosocial function and long-term outcomes yet no pharmacological treatments are currently approved in the United States to treat...
Using Quantitative Systems Pharmacology Modeling to Understand the Pathophysiology of Idiopathic Pulmonary Fibrosis
Patients with idiopathic pulmonary fibrosis (IPF) have a poor survival prognosis and limited treatment options.
Quantitative Systems Toxicology Modeling Using DILIsym Suggests That Drug-Induced Liver Injury (DILI) 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.
A Phase 1b Study of Oral Chk1 Inhibitor LY2880070 as Monotherapy in Patients with Advanced or Metastatic Cancer
In the context of DNA damage, Checkpoint Kinase 1 (Chk1) mediates a checkpoint response which arrests the cell cycle and allows the cell to complete DNA repair and replication.
Relationship between pimavanserin exposure and psychosis relapse in patients with dementia-related psychosis: clinical results and modeling analysis from the phase 3 HARMONY study
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.