Poster: Methodology - Study Design

A Pharmacokinetic-Based Decision Tree to Guide Methods Selection for Safety Evaluation of Infant Systemic Exposure through Human Milk

Thursday 7 May, 2026

Introduction/Objectives: More than 50% of women take at least one medication during lactation. However, 54% of the drugs in the…

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PK/PD-INTEGRATED BAYESIAN PLATFORM DESIGN FOR PHASE II REGIMEN OPTIMISATION

Thursday 7 May, 2026

Introduction: Early-phase dose-finding generally focuses on toxicity, but new approaches are shifting to a more comprehensive quantification of benefit-risks including…

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Translational pharmacology and optimisation of a first-time-in-children protocol for the evaluation of the safety, tolerability, pharmacokinetics and preliminary efficacy of BGA002 in refractory MYCN-altered tumours.

Thursday 7 May, 2026

Introduction MYCN is a key oncogenic driver in several paediatric malignancies, including neuroblastoma, where its amplification is associated with rapid…

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CROSS-PRODUCT POPULATION PHARMACOKINETIC MODELING OF HAEMOGLOBIN S POLYMERIZATION INHIBITORS TO OPTIMISE PAEDIATRIC PK STUDY DESIGN USING STOCHASTIC SIMULATION-ESTIMATION

Thursday 7 May, 2026

Objectives Conducting pharmacokinetic (PK) studies in paediatric populations presents significant challenges due to physiological vulnerability, sampling limitations [1] and ethical…

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Evaluation of the Impact of Machine-learning-informed Optimal Study Design on the Identifiability of Key Pharmacokinetic Parameters in Preclinical Intravenous Rat Pharmacokinetic Studies

Thursday 7 May, 2026

Introduction: Preclinical pharmacokinetic (PK) studies for new drug candidates are typically designed empirically and in a compound agnostic manner. Optimal experimental…

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OPTIMISING SAMPLING DESIGN TO ENHANCE PHARMACOKINETIC EVALUATION OF COLISTIN IN NEONATES

Thursday 7 May, 2026

Background and Objectives: Gram-negative bacteria (GNB) is the most common cause of early onset sepsis (53%) and late onset neonatal…

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Model‑Informed Strategies for Methocarbamol Multi‑Particulate Regimen Development: Linking Mechanistic Modelling to Formulation Design Space

Thursday 7 May, 2026

Objectives: Methocarbamol is a skeletal muscle relaxant that acts by inhibiting polysynaptic reflexes in the spinal cord and subcortical areas….

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Model-Informed Design of Interim Analysis for a PK Bridging Study and Optimization of Its Operating Characteristics

Thursday 7 May, 2026

Introduction PK bridging studies are routinely conducted to extrapolate efficacy from one population in which efficacy has been established (reference…

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MAKING SPARSE DATA INFORMATIVE: POPULATION PHARMACOKINETICS AND D-OPTIMAL DESIGN FOR ORAL CIPROFLOXACIN IN ADULTS ≥75 YEARS

Thursday 7 May, 2026

Objectives: Oral ciprofloxacin remains one of the few available oral agents with activity against Pseudomonas aeruginosa. However, exposure in older…

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Design Evaluation and Optimisation with Discrete Covariates and Inter-Occasion Variability in Nonlinear Mixed Effects Models: The R Package PFIM 7.1

Thursday 7 May, 2026

Objectives Several packages for design evaluation and optimisation in pharmacometrics are based on the Fisher Information Matrix (FIM). The were…

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