Julia Macente
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View article: Systematic Search of Height and Weight Changes of Exclusively Breastfed Infants Until 1 Year of age: A Contribution from the ConcePTION Project
Systematic Search of Height and Weight Changes of Exclusively Breastfed Infants Until 1 Year of age: A Contribution from the ConcePTION Project Open
Physiologically based pharmacokinetic (PBPK) modelling and simulation allows prediction of drug exposure in specific populations, such as infants during lactation. However, the influence of feeding type (e.g., human milk vs formula) on phy…
View article: Predicting Systemic and Liver Bosentan Exposure Using Physiologically‐Based Pharmacokinetic Modeling
Predicting Systemic and Liver Bosentan Exposure Using Physiologically‐Based Pharmacokinetic Modeling Open
Bosentan is the first approved oral medication for pulmonary arterial hypertension, yet the black‐box warning on its labeling implies a substantial risk of liver injury associated with bosentan exposure. The risk assessment of bosentan‐ind…
View article: Pragmatic and contextualized methods selection for safety assessment of infant systemic exposure through human milk: the Milk4baby decision tree approach - a contribution from the concePTION project
Pragmatic and contextualized methods selection for safety assessment of infant systemic exposure through human milk: the Milk4baby decision tree approach - a contribution from the concePTION project Open
More than 50% of women take at least one medication during lactation. However, 54% of drugs in the LactMed database lack lactation safety data, and only 2% have robust evidence. This highlights a significant gap in guidance for designing p…
View article: Predicting Drug Transfer Into Human Milk With the Simcyp Simulator: A Contribution From the <scp>ConcePTION</scp> Project
Predicting Drug Transfer Into Human Milk With the Simcyp Simulator: A Contribution From the <span>ConcePTION</span> Project Open
Physiologically‐based pharmacokinetic (PBPK) modeling can support decision‐making on maternal medication use during breastfeeding. This study aimed to enhance lactation PBPK models in two ways. First, the utility of integrating permeabilit…
View article: Harnessing Open‐Source Solutions: Insights From the First Open Systems Pharmacology (<scp>OSP</scp>) Community Conference
Harnessing Open‐Source Solutions: Insights From the First Open Systems Pharmacology (<span>OSP</span>) Community Conference Open
In 2017, the free and open‐source software Open Systems Pharmacology (OSP) was launched. Since then, OSP has evolved from a small community into a diverse network of stakeholders committed to advancing open‐source solutions for model‐infor…
View article: Challenges Related to Acquisition of Physiological Data for Physiologically Based Pharmacokinetic (PBPK) Models in Postpartum, Lactating Women and Breastfed Infants—A Contribution from the ConcePTION Project
Challenges Related to Acquisition of Physiological Data for Physiologically Based Pharmacokinetic (PBPK) Models in Postpartum, Lactating Women and Breastfed Infants—A Contribution from the ConcePTION Project Open
Physiologically based pharmacokinetic (PBPK) modelling is a bottom-up approach to predict pharmacokinetics in specific populations based on population-specific and medicine-specific data. Using an illustrative approach, this review aims to…
View article: Adult and pediatric physiologically‐based biopharmaceutics modeling to explain lamotrigine immediate release absorption process
Adult and pediatric physiologically‐based biopharmaceutics modeling to explain lamotrigine immediate release absorption process Open
Physiologically‐based biopharmaceutics modeling (PBBM) has potential to accelerate the development of new drug and formulations. An important application of PBBM is for special populations such as pediatrics that have pharmacokinetics depe…
View article: Generic PBPK template for predicting drug concentration time profiles in human breast milk (D3.6)
Generic PBPK template for predicting drug concentration time profiles in human breast milk (D3.6) Open
This deliverable described in the present report reports on the development, evaluation and application of a generic Physiologically-based pharmacokinetic modelling (PBPK) template: To predict medicine concentration time profiles in human …
View article: Generic Workflow to Predict Medicine Concentrations in Human Milk Using Physiologically-Based Pharmacokinetic (PBPK) Modelling—A Contribution from the ConcePTION Project
Generic Workflow to Predict Medicine Concentrations in Human Milk Using Physiologically-Based Pharmacokinetic (PBPK) Modelling—A Contribution from the ConcePTION Project Open
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-base…
View article: Exploring in vitro solubility of lamotrigine in physiologically mimetic conditions to prospect the in vivo dissolution in pediatric population
Exploring in vitro solubility of lamotrigine in physiologically mimetic conditions to prospect the in vivo dissolution in pediatric population Open
Pediatric drugs knowledge still leaves several gaps to be filled, all the while many biopharmaceutic properties applied to adults do not work in pediatrics. The solubility in many cases is extrapolated to pediatrics; however, sometimes it …
View article: PBPK-based dose finding for sildenafil in pregnant women for antenatal treatment of congenital diaphragmatic hernia
PBPK-based dose finding for sildenafil in pregnant women for antenatal treatment of congenital diaphragmatic hernia Open
Sildenafil is a potent vasodilator and phosphodiesterase type five inhibitor, commercially known as Revatio ® and approved for the treatment of pulmonary arterial hypertension. Maternal administration of sildenafil during pregnancy is bein…
View article: Model-informed precision dosing of levetiracetam in pediatrics population
Model-informed precision dosing of levetiracetam in pediatrics population Open
Aims: Assessing the suitability and safety of doses of levetiracetam in pediatrics using physiologic-based pharmacokinetic (PBPK) modeling. Methods: A PBPK model of levetiracetam was developed and validated for healthy adults and scaled fo…