Introduction: Neonatal Fc Receptor (FcRn), which mediates immunoglobulin G (IgG) recycling, is a promising target for treatment of auto-immune diseases….
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COMPARISON OF METHODS TO DEMONSTRATE BIOEQUIVALENCE IN CASE OF HIGH VARIABILITY AND GROUP HETEROGENEITY
Introduction/Objectives: Bioequivalence (BE) studies are conducted to evaluate the similarity in pharmacokinetic (PK) profiles between two drugs or formulations [1,…
Read moreA QUANTITATIVE SYSTEMS PHARMACOLOGY (QSP) MODEL LINKING KIT SIGNALING TO MAST CELL DEGRANULATION AND DEPLETION
Objective: Mast cells (MCs) serve an important role in inflammatory and allergic reactions. KIT, a receptor tyrosine kinase, regulates MC…
Read moreRegulatory-Informed Model Refinement: From Adult-Only to Adult–Pediatric PopPK Integration and its implications
Background Bedaquiline (BDQ), is used to treat pulmonary multidrug -resistant (MDR) tuberculosis (TB) as part of a multi-drug regimen. BDQ…
Read moreMECHANISTIC MODELLING OF CRS IN T CELL ENGAGERS – AN APPLICATION FOR BLINATUMOMAB
Introduction: Blinatumomab is a bispecific T-cell engager (TCE) antibody that simultaneously binds CD3 on T-cells and CD19 on B-cells, thereby…
Read moreTRANSLATIONAL MODELING PLATFORM TO CONNECT IN VITRO POTENCY TO PRECLINICAL WEIGHT LOSS FOR GLP-1 RECEPTOR AGONISTS
Introduction/Objectives The therapeutic landscape for metabolic disorders has been transformed by the increasing number of incretins, which demonstrate varying degrees…
Read moreQuantifying host and vaccination determinants of viral dynamics in respiratory infections using community-based PCR data
Introduction: Influenza viruses, respiratory syncytial virus (RSV), and SARS-CoV-2 drive recurrent seasonal epidemics and impose a substantial healthcare burden[1–3]. Since…
Read moreFrom mother to newborn: pregnancy PBPK-PD modeling for rozanolixizumab
Objectives: For women living with chronic autoimmune diseases, adequate disease control during pregnancy is key to ensure the best maternal…
Read morePOPULATION PHARMACOKINETIC MODEL OF EXTENDED-RELEASE METFORMIN IN OBESE SOUTH AFRICAN WOMEN WITH HIV RECEIVING DOLUTEGRAVIR
Introduction: The antiretroviral drug dolutegravir (DTG) inhibits the renal organic cation transporter 2, the primary elimination pathway for the glucose-lowering…
Read moreReference-Corrected VPCs: Addressing Model Evaluation Challenges with Real-World Data and Adaptive Designs
Background The visual predictive check (VPC) and the prediction-corrected VPC (pcVPC) are standard diagnostic tools used to evaluate the suitability…
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