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

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Pharmacokinetics and Pharmacodynamics".

Deadline for manuscript submissions: 1 September 2023 | Viewed by 1171

Special Issue Editors

Pharmacometrics/Modeling and Simulation, Research and Development, Pharmaceuticals, Bayer AG, 51373 Leverkusen, Germany
Interests: PBPK; pregnancy; lactation; maternal–fetal; neonates
1. Department of Development and Regeneration, KU Leuven, Leuven, Belgium
2. Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium
3. Department of Clinical Pharmacy, Erasmus Medical Center, Rotterdam, The Netherlands
Interests: perinatal pharmacology; neonatal clinical pharmacology; PBPK in special populations; newborn; infant; lactation
Special Issues, Collections and Topics in MDPI journals
1. Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, IN, USA
2. Division of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, IN 46202, USA
Interests: obstetric pharmacology; pediatric pharmacology; PBPK; pharmacometrics; maternal-fetal; special populations; translational informatics

Special Issue Information

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

Manuscript Submission Information

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

Published Papers (1 paper)

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Generic Workflow to Predict Medicine Concentrations in Human Milk Using Physiologically-Based Pharmacokinetic (PBPK) Modelling—A Contribution from the ConcePTION Project
Pharmaceutics 2023, 15(5), 1469; https://doi.org/10.3390/pharmaceutics15051469 - 11 May 2023
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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 [...] Read more.
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 (Cmax) 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
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