Abstracts of the 2024 International Congress of the European Academy of Paediatrics (EAP) and the European Society for Paediatric Research (ESPR)

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Background and Aims: Infant physiology evolves quickly during the first year of life and differences have been reported between formula-and breastfed infants.Insufficient knowledge of these physiological differences is a limitation when applying physiologically based pharmacokinetic (PBPK) modelling to predict lactation related drug exposure in the infant.Methods: A systematic literature search regarding breastfed infant physiology included 223 articles.Height and weight data were extracted and pooled to a mean and standard deviation during the first 12 months.This dataset was compared to different equations from literature, including National Center for Health Statistics (NCHS) and Simcyp functions.A polynomial trendline was generated for our dataset via Microsoft Excel, along with a trendline for world health organization (WHO) and PK-Sim data.Results: Comparison of our dataset to different height and weight equations is depicted in Figure 1.Visual differences are observed between this dataset and functions, e.g., the PBPK platform default functions.Conclusions: The differences between currently applied functions in PBPK software and this dataset imply an inadequate prediction for breastfed infants using PBPK models.Other aspects of infant physiology like body composition should also be studied using the same systematic methodology to assess their impact on PBPK predictions.

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