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.
Delineating the Complex Interplay of Enzymes and Transporters Governing the Absorption and Disposition of Atorvastatin and the Metabolites Using Physiologically Based Pharmacokinetic (PBPK) Modeling
Atorvastatin (ATS) is widely used to treat high cholesterol and potentially lower the risk of cardiac complications.
A phase 1b dose escalation study of CD137 mAb agonist OC-001 as monotherapy in patients with advanced or metastatic cancer
OC-001 is a CD137 mAb agonist designed to show differential agonistic activity from that of competitor
antibodies. OC-001 provided T cell activation that
Physiologically Based Pharmacokinetic (PBPK) Modeling of Pyrotinib to Understand the Impact of Interplay Between CYP3A4 and P-GP on its DDIs with CYP3A4 Inhibitors/Inducers
To develop a PBPK model for pyrotinib and qualify it with the in vivo data obtained after oral administrations.
Implementation of a Physiologically Based Pharmacokinetic Modeling Approach to Predict Disease-Related Changes in Drug Pharmacokinetics in Patients with Nonalcoholic Fatty Liver Disease Conference name: International Society for the Study of Xenobiotics (ISSX)-Microsomes and Drug Oxidations (MDO) Joint Meeting
Introduction: Understanding disease-related changes in the pharmacokinetics of drugs in patients with nonalcoholic fatty liver disease (NAFLD) is of clinical importance...
Absence of association between abatacept exposure levels and initial infection in patients with RA: a post hoc analysis of the randomized, placebo-controlled AVERT-2 study
Infections are the most commonly reported AEs in patients with RA treated with immunosuppressive therapies, and
Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Moxifloxacin Solution Case Study
Development of generic ophthalmic drug products is challenging due to the complexity of the ocular system and a lack of sensitive...
Physiologically based pharmacokinetic (PBPK) simulations and modeling of botanical constituents
Botanicals have broad use as traditional medicines, natural health products, and dietary supplements around the world.
Modeling of Cyclosporine A-Induced Acute Kidney Injury with RENAsym®
Cyclosporine A (CsA) is an immunosuppressant commonly used to prevent organ rejection and can be used to treat other diseases such as...
Mechanistic modeling of biologics-induced liver injury (BILI) predicts hepatotoxicity of Tocilizumab through both on- and off-target effects
Biologics address a range of unmet medical needs. However, there are
increasing numbers of BILI cases which slow therapeutic development...
Simulating Multidrug Resistance Protein 3 (MDR3) Inhibition-Mediated Cholestatic Liver Injury Using DILIsym X, a Quantitative Systems Toxicology (QST) Modeling Platform
Inhibition of efflux transporters located on the canalicular membrane of hepatocytes is an important mechanism of cholestatic liver injury, which is...
Quantitative Systems Toxicology (QST) Modeling of Cimaglermin Alfa (GGF2) Hepatotoxicity Shows the Potential of BIOLOGXsym to Predict Biologics-Induced Liver Injury (BILI)
Biologics continue to address various unmet medical needs, but the occurrence of BILI can terminate clinical...
Modeling of Indinavir-Induced Crystal Nephropathy in RENAsym®
Indinavir, a protease inhibitor used to treat patients with HIV/AIDS, is known to induce crystal nephropathy. This is...
Evaluating Nephrotoxicity of Cisplatin in Rats with RENAsym, a Mechanistic Model of Drug-Induced Acute Kidney Injury
Acute kidney injury (AKI) is often initiated by cellular toxicity of proximal tubule epithelial cells (PTEC) when...
Furthering the clinical development of navicixizumab in advanced epithelial ovarian cancer patients with a population pharmacokinetic model and exploratory exposure-safety-efficacy response analyses
Navicixizumab is a first-in-class, bispecific, anti-angiogenic antibody to vascular endothelial growth factor (VEGF) and
Using artificial intelligence to design BACE1 inhibitors
β-secretase 1 (BACE1) is an enzyme involved in production of amyloid-βpeptides, which are involved in the pathology of Alzheimer’s disease.
Quantitative Systems Pharmacology Modeling of FGF19 Pathway Using NAFLDsym Prospectively Predicted Liver Fat and Serum Biomarker Responses to MET409 in NASH Patients
Treatment of nonalcoholic steatohepatitis (NASH) is a significant unmet medical need. In this work...
Proof-of-concept Simulations Using BIOLOGXsym, a Novel Quantitative Systems Toxicology (QST) Modeling Platform for Predicting Biologics-induced Liver Injury (BILI), Recapitulate Clinically Observed Hepatotoxicity of GGF2
While biologics continue to address various unmet medical needs, BILI can terminate clinical development...
Population pharmacokinetic modeling and stochastic simulations to support pediatric dose selection of pimavanserin
pimavanserin-is-a-selective-serotonin-receptor-modulating-agent-with-inverse-agonist-antagonist-activity-at-the-5ht2a-receptor-and-to-a-lesser
Validation of non-compartmental analysis (NCA) and bioequivalence results of PKanalix with respect to Phoenix WinNonLin
Non-compartmental analysis (NCA) is used at all stages of drug development and is a key method to understand the pharmacokinetic properties of a compound.