The PBPK model for rivoceranib, an anticancer drug acting as a tyrosine kinase inhibitor (TKI) that selectively targets vascular...
Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Besifloxacin Suspension Case Study
The purpose of this research is to demonstrate the ability of O-PBPK models, validated against rabbit PK data, to predict clinical ocular exposure, following topical administration of ophthalmic suspensions
Validation of PBPK-Based Translation to Predict Monoclonal Antibody Pharmacokinetics in Pediatric Populations
Accurate prediction of the pediatric dose is a necessity before conducting a clinical trial or using a drug product in standard clinical practices.
Predicted Pharmacokinetic Properties of Botanical Constituents
Botanicals are used as traditional medicines, natural health products, and dietary supplements globally.
Pharmacokinetic/pharmacodynamic analysis of apixaban to determine dosing regimens for pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma treated with asparaginase: analysis from the PREVAPIX study
Apixaban is an orally active, direct selective inhibitor of coagulation factor Xa (FXa),1 and may be a treatment option for prevention of venous thromboembolism (VTE) in children with...
Modeling and simulation to support apixaban dose recommendation for thromboembolism prevention in pediatric subjects with congenital or acquired heart disease requiring anticoagulation–saxophone study
Apixaban is an oral, direct, selective factor Xa (FXa) inhibitor1 and may be a treatment option for venous thromboembolism prevention in...
A validated PBPK model is used in lieu of clinical studies to assess the risk of CYP3A4-mediated DDIs for an anticancer drug rivoceranib (victim) with weak/moderate CYP3A4 inhibitors (ranitidine/fluconazole), or with a moderate CYP3A4 inducer (efavirenz)
A PBPK model for anticancer drug rivoceranib (RIV), a tyrosine kinase inhibitor (TKI) that selectively targets vascular endothelia growth factor...
Attenuations in adiponectin production over time restrict simulated efficacy for pegbelfermin in F3 NASH patients
Patients with non-alcoholic steatohepatitis (NASH) and fibrosis do not currently have options for...
Greater efficacy predicted for FGR1/beta-klotho receptor agonists that achieve 60% or greater increases in serum adiponectin
The FGFR1/beta-klotho receptor (FGFR1/KLB) in adipose has been demonstrated to be a...
Reduction of daily moderate alcohol intake predicted to decrease fibrosis stage in patients with non-alcholic steatohepatitis
Several recently completed clinical trials in NASH patients have included fibrosis stage reductions in...
Mathematical Representation of Drug-Induced Crystal Nephropathy Using a Quantitative Systems Toxicology Approach
Drugs may cause crystal nephropathy by precipitating within kidney tubules or inducing...
Mathematical Modeling of Renal Sodium, Potassium, and Glucose Dynamics in Diabetic and Non-Diabetic Simulated Populations
Type 2 diabetic (T2D) patients often exhibit reduced systolic and diastolic functions, which can place them at...
Representation of Fibrosis Stage Within Mechanistic Model of Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alchoholic Steatohepatitis (NASH) Aligns with Histologic Assessments
NAFLD encompasses a histological spectrum of liver pathophysiology ranging from steatosis to NASH and may result in cirrhosis and ultimately liver failure. A reduction in fibrosis stage, which...
Proof-of-concept that Variable Onset and Severity of T cell-mediated Drug-Induced Liver Injury is Reproduced in a Simulated Human Population
Idiosyncratic drug-induced liver injury (iDILI) is a rare, but often serious, adverse reaction that can compromise drug development. For some iDILI compounds¹, the...
Physiologically Based Pharmacokinetic (PBPK) Modeling of Rifampicin and Its Application for Drug-Drug Interaction with Midazolam in Adults
Rifampicin (RIF) is an essential part of tuberculosis therapy and the pharmacokinetics (PK) of RIF has been of interest due to its non-linear and auto-induction behavior
Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Gatifloxacin Solution Case Study
Development of generic ophthalmic drugs has been extremely challenging due to the complexity of the ocular system and a lack of sensitive testing tools to evaluate its interplay with ophthalmic formulations.
Predicting the Efficacy of Obeticholic Acid Treatment for Non-Alcoholic Steatohepatitis (NASH) Using NAFLDsym, a Quantitative Systems Pharmacology Model of Non-Alcoholic Fatty Liver Disease
Obeticholicacid (OCA), a bile acid analog and agonist of the farnesoidX receptor (FXR), is currently in clinical trials for the treatment of non-alcoholic steatohepatitis (NASH).
Establishment of preclinical mechanistic in vitro-in vivo correlations for long-acting injectable suspensions
Long acting injectable (LAI) formulations administered through subcutaneous (SC) or intramuscular (IM) routes provide sustained drug release over an extended period.
ILDsym®, a Quantitative Systems Pharmacology (QSP) Platform, Successfully Simulates the Pathophysiology of Systemic Sclerosis-Interstitial Lung Disease (SSc-ILD) and Inter-patient Variability
Systemic sclerosis (SSc) is a rare connective tissue and autoimmune disease associated with inflammation of the skin and internal organs.
Use of Quantitative Systems Toxicology (QST) to Identify Potential Intrinsic Mechanisms of Toxicity
BAY1128688, a selective inhibitor of aldo-keto reductase family 1 member C3 (AKR1C3), was in clinical trials as a potential therapy to provide pain relief for women with endometriosis.