Biopharmaceuticals are increasingly used to treat various medical conditions, but BILI events can end...
Advancing the Multi-Targeted Mechanisms of Action of a Mitochondrial Activator (AXA1125) for Treating NASH Using a Quantitative Systems Pharmacology Model
Patients with non-alcoholic steatohepatitis (NASH) do not currently have options for pharmaceutical...
ILDSYM®, A Quantitative Systems Pharmacology (QSP) Platform, Successfully Simulates Efficacy of Key Treatments for Systemic Sclerosis-Interstitial Lung Disease
Systemic sclerosis (SSc) is a rare connective tissue and autoimmune disease associated with inflammation of the skin and internal organs. Interstitial lung disease (ILD), a frequent complication of SSc with highly variable course, is associated with increased morbidity and mortality risk¹. Two FDA-approved treatments, anti-inflammatory tocilizumab (TCZ) and anti-fibrotic nintedanib (NIN)...
Accelerating a QSP Model of Nonalcoholic Steatohepatitis (NASH) Using the Julia Language
NAFLDsym® is a quantitative systems pharmacology (QSP) platform that simulates progression and treatment of nonalcoholic fatty liver...
Mechanistic Representation of NAG Release in Relation to Renal Proximal Tubular Cellular Injury
Novel Acute kidney injury (AKI) biomarkers enhance disease understanding and aid...
Automated covariate selection: SAMBA and COSSAC algorithms
COSSAC Conditional Sampling use for Stepwise Approach based on Correlation tests
SAMBA Stochastic Approximation for Model Building Algorithm
Development of an Ocular PBPK-PD model to predict drug-mediated intraocular pressure reduction in preclinical species
Glaucoma, caused by an elevation of the intra-ocular pressure (IOP), leads to vision loss
The QST modeling approach leveraging known physiology and available clinical data paves the path towards predictions of DILI in pediatrics
Drug-induced liver injury (DILI) is an underrecognized cause of pediatric liver disease which accounts for almost...
Refining Predictions of Food Effects on Drug Absorption: Models Predicting Gastric Emptying and Bile Concentrations Based on Fat Content and Caloric Intake
In the realm of pharmaceutical R&D, the quest for enhanced predictive accuracy and efficiency for Fed State PBPK models has never been more pressing.
Mechanistic modeling of intramuscular administration of long-acting injectable suspensions accounting for fibrosis at the depot site
Antipsychotic drugs formulated as long-acting injectables (LAIs) significantly improve patient compliance compared to regimens that require daily oral administration.
Physiologically Based Pharmacokinetic (PBPK) Modeling of Fexofenadine and Assessment of Transporter DDIs of Fexofenadine with P-gp inducers and inhibitors
Fexofenadine (FEX), a H1-receptor antagonist used in the treatment of allergic rhinitis and chronic idiopathic urticaria, undergoes minimal metabolism and transporters play a major role in its absorption and disposition.
Physiologically Based Pharmacokinetic (Pbpk) Oral Absorption Model To Predict Mucosal Permeability of Oral Cavity Drug Products
Buccal delivery allows bypassing first-pass metabolism
Population pharmacokinetic modelling to confirm weight-based banded dosing and exposure-response efficacy analyses to support trofinetide treatment in rett syndrome
Trofinetide, a synthetic analog of glycine-proline-glutamate, was approved by the US Food and Drug Administration in March 2023 for the treatment of...
Predictive performance of physiologically based kinetic (PBK) models based on in silic o/ in vitro to in vivo extrapolation (IS/IVIVE)
The applicability of PBK modelling in next generation risk assessment ( hinges on accurate prediction of human plasma concentrations without reliance on animal in vivo kinetics data.
Development of an in silico model of topical acyclovir to explore formulation design
Acyclovir (ACY) creams are used for local treatment of HSV-1 infections in the basal epidermis.
Development of Silica Release Model for Intraocular Injections
This poster reviews the development of a numerical framework within DDDPlus™ (Version 6.0, Simulations Plus, Inc.) to simulate the degradation and drug...
Population pharmacokinetics of vadadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor for treatment of anemia associated with chronic kidney disease
Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, a class of...
Establishment of Virtual Bioequivalence via DoE-PBBM Model: A Donepezil Case Study
Donepezil (DZP) is a medication used to treat Alzheimer's disease.
The application of AI-driven Drug Discovery technology for molecular optimization of nuclear receptor ligands
Nuclear receptors (NRs) are a superfamily of transcription factors whose activity is regulated upon the binding of a specific ligand.
Physiologically-Based Pharmacokinetic Modelling of Rivoceranib Parent and Metabolite to Project DDI Risk and Support Regulatory Decision-Making
The PBPK model for rivoceranib, an anticancer drug acting as a tyrosine kinase inhibitor (TKI) that selectively targets vascular...