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

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 pharmacokinetic and safety studies characterizing infant safet...

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Main Authors: Anaëlle Monfort, Julia Macente, Martje Van Neste, Miao-Chan Huang, Nina Nauwelaerts, Getahun Befirdu Abza, Ursula Winterfeld, Anne Smits, Karel Allegaert, Pieter Annaert, Monia Guidi, Alice Panchaud
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-08-01
Series:Frontiers in Pharmacology
Subjects:
lactation
infant exposure
medication safety
pharmacokinetics
clinical lactation studies
risk assessment
Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2025.1602018/full
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https://www.frontiersin.org/articles/10.3389/fphar.2025.1602018/full

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