Introduction: This work introduces a novel effort to use immune response biomarkers to help identify covariates affecting vaccine efficacy (VE)….
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A method to estimate probability of disease and vaccine efficacy from clinical trial immunogenicity data
Introduction: Protective efficacy of a vaccine is defined as the proportional reduction in risk of disease among vaccinated subjects compared…
Read moreLogistic regression-based approach to assess heterogeneity in vaccine efficacy using immunogenicity measurements in phase 3 clinical trials
Objectives: This work introduces a novel use of immune response biomarkers to help identify baseline covariates affecting vaccine efficacy (VE). …
Read morePhysiological Response to Endotoxin Infusion in the Piglet: Modelling of changes in hemodynamic outcomes
Introduction: Sepsis is a life-threatening clinical condition resulting from exaggerated immune activation, often in response to bacterial infection, and it…
Read morePharmacokinetics of vancomycin in the cerebrospinal fluid in critically ill patients
Introduction: Although the penetration into the central nervous system is believed to be poor, vancomycin is the recommended therapy in…
Read morePredictive Primates: Enabling Rapid Go/No-Go Decisions on COVID-19 Vaccine Candidates with a Predictive, Translational MBMA and Clinical Immunogenicity Data
Objectives: The Covid-19 pandemic is motivating extraordinarily rapid development of safe and efficacious vaccines against SARS-CoV-2, increasing the need for…
Read moreMS TreatSim: A clinical trial simulator for Relapsing-remitting Multiple Sclerosis
Introduction: In the last decades, Relapsing-remitting Multiple Sclerosis (RRMS) diagnostic methodology and treatment options have undergone great improvements [1–3], positively…
Read moreSimulating maximum tolerated dose-finding oncology trials using the InSilicoTrials cloud-based platform
Introduction: In silico clinical trials are expected to play an increasingly important role in guiding the design of oncology phase I…
Read moreExploring the Relationship Between Midazolam Concentrations And Level Of Sedation In Critically-Ill Mechanically Ventilated Children Using Markov Modelling
Objectives: While knowledge on the pharmacokinetics (PK) of midazolam in children of various ages and with various disease conditions is…
Read moreUse of informative priors in model-informed drug development
Objectives: To introduce methods for constructing informative priors from historical data or by elicitation from experts To discuss different methods…
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