34th PAGE Meeting

Dubrovnik - Croatia
2-5 June, 2026

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Abstracts (15)

I-106Stefano Grosdani

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.

Wed, Jun 3, 2026 10:30AM–12:00PM

I-107France Mentré

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

Wed, Jun 3, 2026 10:30AM–12:00PM

I-108Keqi Shi

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

Wed, Jun 3, 2026 10:30AM–12:00PM

I-109Daria Zhuravleva

APPLICATION OF CONTINUOUS-CATEGORICAL IRT MODELLING TO ENHANCE STATISTICAL POWER IN N-OF-1 TRIALS: SIMULATION-BASED EVALUATION

Wed, Jun 3, 2026 10:30AM–12:00PM

II-106Helene Haguet

MODEL-BASED META-ANALYSIS POPULATION PK MODELING OF ANTI-IL-5(RΑ) MONOCLONAL ANTIBODIES TO OPTIMIZE PEDIATRIC STUDY DESIGN USING STOCHASTIC SIMULATION-ESTIMATION

Wed, Jun 3, 2026 3:20PM–4:50PM

II-107Anaëlle Monfort

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

Wed, Jun 3, 2026 3:20PM–4:50PM

II-108Monika Twarogowska

Model-Informed Biosimilar Study Design Under Evolving Regulatory Guidance: Dose Selection and Power Optimization in Pegfilgrastim

Wed, Jun 3, 2026 3:20PM–4:50PM

III-105Mehdi El Hassani

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

Thu, Jun 4, 2026 9:50AM–11:20AM

III-106Ziheng Hu

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

Thu, Jun 4, 2026 9:50AM–11:20AM

III-107Veshni Pillay-fuentes Lorente

OPTIMISING SAMPLING DESIGN TO ENHANCE PHARMACOKINETIC EVALUATION OF COLISTIN IN NEONATES

Thu, Jun 4, 2026 9:50AM–11:20AM

III-108Pyry Valitalo

Paediatric pharmacokinetic studies could be optimized for the precision of the clinically relevant exposure endpoint instead of PK parameter precision

Thu, Jun 4, 2026 9:50AM–11:20AM

IV-105Grace Shalom Govere

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

Thu, Jun 4, 2026 1:40PM–3:10PM

IV-106Loes Maton

Advancing sample size justifications in confirmatory paediatric exposure-matching trials submitted to regulatory authorities: a benchmarking analysis and novel methodological framework.

Thu, Jun 4, 2026 1:40PM–3:10PM

IV-107Kevser Sevim

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

Thu, Jun 4, 2026 1:40PM–3:10PM

IV-108Axel Vuorinen

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

Thu, Jun 4, 2026 1:40PM–3:10PM