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First received: September 13, 2022

Clinical Trial: Drug Concentrations in Breast Milk and Prediction of Blood Levels of the Breastfed Infants

Study Status: Completed

Recruit Status: RECRUITING

Condition: Breast Feeding

Study Type: OBSERVATIONAL


Official Title: Drugs in Breast Milk

Brief Summary: There is a significant lack of information on drug secretion into milk and infant exposure.As a first step to address this issue, the investigators examine milk concentrations of selected drugs prescribed to breastfeeding women, which lack milk excretion data.Milk data will be analyzed using population pharmacokinetic approaches, when possible, and acquired data of drug concentration profiles in milk will be combined with infant physiologically-based pharmacokinetic (PBPK) models to predict infant exposure levels.

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