Introduction: Dexmedetomidine (DEX) is a relatively new sedative agent with a growing use in the pediatric population. However, limited data…
Read morePoster: Drug/Disease Modelling - CNS
Nipocalimab Dose Selection for A Phase 3 Study in Adult Patients with Generalized Myasthenia Gravis
Background: Nipocalimab (JNJ-80202135) is a fully human IgG1λ monoclonal antibody that blocks neonatal Fc receptors (FcRn) inhibiting IgG recycling and…
Read moreDevelopment of a Population Pharmacokinetic Model to Describe the Pharmacokinetics of Aripiprazole 2-Month Ready-to-Use, a Novel Long-Acting Injectable Formulation of Aripiprazole for Administration Once Every 2 Months
Introduction: Compared with oral antipsychotics, long-acting injectable (LAI) antipsychotic formulations are associated with greater treatment adherence and a reduced risk…
Read moreModeling decline in cognition to decline in function in Alzheimer’s disease
Introduction: Alzheimer’s disease (AD) is a degenerative brain disease and the most common form of dementia. Current research is focusing…
Read morePopulation pharmacokinetic model for levodopa/carbidopa microtablets in Parkinson’s disease patients and healthy subjects
Objectives: Low dose, dispersible, levodopa/carbidopa microtablets with an automatic dose dispenser, have been developed as a therapy to facilitate individualized…
Read moreA Bayesian approach for population pharmacokinetic modeling of alcohol in Japanese Subjects
Objectives: To explore significant covariates for the population pharmacokinetic analysis of alcohol by incorporating external data using a Bayesian method, and…
Read morePopulation pharmacokinetics and exposure-response analyses of amyloid PET SUVr and plasma biomarkers Aβ42/40 ratio and p-tau181 for lecanemab in subjects with early Alzheimer’s disease
Introduction/Objectives: Lecanemab (BAN2401) is a humanized immunoglobulin G1 monoclonal antibody that selectively binds to soluble Aβ aggregate species, while demonstrating…
Read moreItem response theory modelling of motor scores to investigate feasibility of reducing proof-of-concept trial for Parkinson’s disease
Objectives: Parkinson’s disease (PD) is a progressive condition. The total score of Part III (Motor Examination), a composite of 33…
Read moreTwo-step modelling approach of time to event and cognitive decline to inform Alzheimer’s disease prevention trials
Objectives: Optimal clinical trial designs to evaluate innovative treatments[1] are needed to test disease-modifying interventions in the Alzheimer’s disease (AD)…
Read morePopulation PK and exposure-response analysis of sleep parameters for JNJ-42847922, a novel Orexin 2 receptor antagonist
Objectives: The orexin system regulates wake-sleep states. [1] Orexin 2 receptor (OX2R) blockade may be a novel pharmacological approach to…
Read more