Objectives: Thrombocytopenia is one of the most common adverse events in oncology drug development, which is often a dose-limiting factor…
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From mechanistic insight to parsimonious models: Modelling IL-18 and aletekitug to inform target engagement
Objectives Interleukin-18 (IL-18) is a pro-inflammatory cytokine that amplifies innate and adaptive immune responses. In circulation, IL-18 is tightly regulated…
Read moreModel Averaging for Individual Predictions in Joint Nonlinear Mixed-Effects Models
Introduction Nonlinear mixed-effects models (NLMEMs) are widely used in model-informed precision dosing (MIPD), particularly in pharmacokinetic–pharmacodynamic (PK/PD) analyses in which…
Read moreBOUNDED INTEGER MODELING OF NEUROPATHY, QUALITY OF LIFE AND ACUTE ADVERSE EVENT SCALES IN PATIENTS WITH COLORECTAL CANCER
Introduction: Oxaliplatin-based chemotherapy is vital for patients with colorectal cancer [1]. However, the treatment can cause serious side effects such…
Read moreA semi-mechanistic model describing tumor response to oncolytic virus and anti-PD-1 therapy in preclinical studies
Introduction. Oncolytic viruses (OVs) are a promising therapeutic strategy in oncology due to their dual mechanism of action: direct oncolytic…
Read moreFood effect prediction of high permeability/low solubility compound, formulated as an amorphous solid dispersion (ASD) using an Open Systems Pharmacology (OSP) PBBM approach
Introduction: Model-Informed Drug Development (MIDD) approaches are increasingly encouraged by regulatory agencies and adopted across the pharmaceutical industry to streamline…
Read morePopulation Pharmacokinetic and Pharmacodynamic Modeling of Canagliflozin in Paediatric Patients with Type 2 Diabetes Mellitus
Introduction: Type 2 diabetes mellitus (T2DM) is a chronic, progressive metabolic disorder that impacts patients across a broad age range…
Read morePOPULATION PHARMACOKINETIC-PHARMACODYNAMIC MODELLING OF FOLLICLE-STIMULATING HORMONE AND INHIBIN-B TO PREDICT OVARIAN RESPONSE TO FOLLITROPIN ALFA IN IN VITRO FERTILISATION PATIENTS
Introduction/Objectives: Controlled ovarian hyperstimulation (COH) in women undergoing in vitro fertilisation (IVF) involves daily administration of recombinant follicle-stimulating hormone (FSH;…
Read moreInitialising a structured framework to generate virtual patient cohorts in support of drug development in rare and pediatric diseases: Collating and developing methodological modelling and simulation techniques under scenarios of limited knowledge availability
Introduction: Drug development is challenging in rare and pediatric diseases, due to recruitment limitations and ethical constraints. Generation of virtual…
Read moreA framework for nlmixr2auto: an open-source R package on CRAN for automated population pharmacokinetic modelling
Introduction/Objectives. Population pharmacokinetic modelling (PopPK) is an essential tool in drug development and clinical practice, supporting dose optimisation and individualised…
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