Thursday 16 October, 2025
Objectives: Combination therapies may dramatically improve the outcome for cancer patients, and it is expected that such Therapies will eventually…
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Population pharmacokinetic modeling of total active moiety exposure following doses of TV 46000, a long-acting subcutaneous risperidone injection
Thursday 16 October, 2025
Background: TV‑46000 is a long-acting subcutaneous (sc) risperidone injection in development for treatment of schizophrenia with flexible dosing either once monthly…
Read morePhysiologically-based pharmacokinetic (PBPK) modelling of nicotine and its main metabolite cotinine in healthy volunteers and smokers
Thursday 16 October, 2025
Introduction: Since nicotine is the pharmacologically active substance in tobacco responsible for addiction it also plays a distinctive role in…
Read morein vitro PK/PD modeling of immunological synapse-based tumor cell killing and immune activation to predict in vitro efficacy of T-Cell Bispecifics.
Thursday 16 October, 2025
Introduction: T-Cell Bispecifics (TCBs) are antibody constructs with binding specificities to both a tumor antigen and T cell receptor allowing…
Read moreMathematical Modeling of Glucose Homeostasis in Morbidly Obese Diabetic Patients Undergoing Roux-en-Y Gastric Bypass Surgery: An IMI DIRECT Study
Thursday 16 October, 2025
Introduction/Objectives: Type 2 diabetes mellitus (T2DM) is a complex multifactorial disorder, impacted by several genetic and environmental factors. Overweight and obesity…
Read moreDevelopment of a tool for fully automatic model development (AMD)
Thursday 16 October, 2025
Introduction/Objectives: The development of a population pharmacokinetic (PK) model is a challenging and time-consuming procedure that involves iterative manual model…
Read moreA PK-PD modelling and simulation-based evaluation of tedizolid dosing strategies for immunocompromised patients
Thursday 16 October, 2025
Objectives: Tedizolid (TDZ) is a clinically useful antibiotic with efficacy against Gram-positive bacteria. The currently recommended dose to treat skin…
Read moreA review of population PK and exposure-response models reported in FDA oncology submission documents
Thursday 16 October, 2025
Objectives: Population pharmacokinetic (popPK) and exposure-response (ER) modelling are the critical components of United States Food and Drug Administration (FDA)…
Read moreModelling tissue pharmacokinetics: A comparison of empiric and mechanistic PBPK modelling approaches of different complexity exemplified with moxifloxacin
Thursday 16 October, 2025
Objectives: Suboptimal tissue site exposure is a critical factor for therapeutic failure, potentially stimulating antibiotic resistance and is hence crucial to…
Read moreImplementation of event time distribution as a random effect in time-to-event analysis
Thursday 16 October, 2025
Introduction: Different distributions of event times considered in time-to-event (TTE) analysis are well documented. These distributions include the exponential, Weibull,…
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