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Special Issue "Physiologically-Based Pharmacokinetic Modeling in Pregnancy, Lactation, and in Neonates: Achievements, Challenges and Future Directions"

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Dear Colleagues,

Obstetric patients represent a special population in drug therapy. During pregnancy and in the postpartum period, various anatomical and physiological changes give rise to altered drug pharmacokinetics in both the mother and fetus or neonate, yet pregnant and lactating women and their infants are underrepresented in clinical trials, leading to a dearth of in-depth information on the drug pharmacokinetics in these populations. Consequently, dosing regimens are often simply extrapolated from non-pregnant to pregnant women or allometrically scaled from adults to neonates, entailing in both cases considerable risks of sub-therapeutic or toxic drug effects for the mother, fetus, and/or neonate.

In recent years, tremendous efforts have been directed towards investigating drug pharmacokinetics in obstetric populations or infants through various approaches, including physiologically based pharmacokinetic (PBPK) models. This reflects an increased awareness of the necessity to better understand clinical pharmacology and ultimately improve pharmacotherapy in this vulnerable patient population.

The goal of this Special Issue is to showcase strong examples of a successful application of PBPK modeling approaches in the obstetric population as well as to present the status quo and an outlook on future perspectives of this technology in the field of obstetric pharmacology.

We invite articles on all aspects of PBPK modeling in pregnant, lactating, or neonatal populations for this Special Issue.

Dr. André Dallmann
Prof. Dr. Karel Allegaert
Dr. Sara Quinney
Guest Editors

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Keywords

PBPK modeling
modeling and simulation
pharmacokinetics
pregnancy
maternal–fetal
lactation
neonates
infants

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Open AccessArticle

Generic Workflow to Predict Medicine Concentrations in Human Milk Using Physiologically-Based Pharmacokinetic (PBPK) Modelling—A Contribution from the ConcePTION Project

Nina Nauwelaerts

Julia Macente

Neel Deferm

Rodolfo Hernandes Bonan

and

Pharmaceutics 2023, 15(5), 1469; https://doi.org/10.3390/pharmaceutics15051469 - 11 May 2023

Viewed by 784

Abstract

Women commonly take medication during lactation. Currently, there is little information about the exposure-related safety of maternal medicines for breastfed infants. The aim was to explore the performance of a generic physiologically-based pharmacokinetic (PBPK) model to predict concentrations in human milk for ten physiochemically diverse medicines. First, PBPK models were developed for “non-lactating” adult individuals in PK-Sim/MoBi v9.1 (Open Systems Pharmacology). The PBPK models predicted the area-under-the-curve (AUC) and maximum concentrations (C_max) in plasma within a two-fold error. Next, the PBPK models were extended to include lactation physiology. Plasma and human milk concentrations were simulated for a three-months postpartum population, and the corresponding AUC-based milk-to-plasma (M/P) ratios and relative infant doses were calculated. The lactation PBPK models resulted in reasonable predictions for eight medicines, while an overprediction of human milk concentrations and M/P ratios (>2-fold) was observed for two medicines. From a safety perspective, none of the models resulted in underpredictions of observed human milk concentrations. The present effort resulted in a generic workflow to predict medicine concentrations in human milk. This generic PBPK model represents an important step towards an evidence-based safety assessment of maternal medication during lactation, applicable in an early drug development stage. Full article

(This article belongs to the Special Issue Physiologically-Based Pharmacokinetic Modeling in Pregnancy, Lactation, and in Neonates: Achievements, Challenges and Future Directions)

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Special Issue "Physiologically-Based Pharmacokinetic Modeling in Pregnancy, Lactation, and in Neonates: Achievements, Challenges and Future Directions"

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