Health AI Central
Peer-Reviewed Publication
Pharm Res2026October 12, 2026Journal Article

Development of a Mechanistic Distribution Model for Predicting Drug Partitioning into Human Milk.

Neel Deferm1,2, Anna Murphy3, Iain Gardner3, Khaled Abduljalil3
1Predictive Technologies Division, Certara UK Limited, Simcyp Division, 1 Concourse Way, Level 2-Acero, Sheffield, S1 2BJ, UK. neel.deferm@certara.com.
2Pharmides BV, Pelt, Belgium. neel.deferm@certara.com.
3Predictive Technologies Division, Certara UK Limited, Simcyp Division, 1 Concourse Way, Level 2-Acero, Sheffield, S1 2BJ, UK.
PubMed DOI

Abstract

PURPOSE/OBJECTIVE: Limited clinical data on drug safety during lactation complicate benefit-risk assessment for breastfeeding women who require pharmacotherapy. Mechanistic prediction of the milk-to-plasma ratio within physiologically-based pharmacokinetic frameworks offers a complementary and efficient approach to traditional clinical lactation studies. We aimed to develop a mechanistic milk part…

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