Three major areas are emphasized for a study of drug excretion in breast milk: maternal drug disposition, breast milk pharmacokinetics and neonatal drug elimination. The first two impact on drug dose to infant whereas the last area is crucial to drug accumulation in the infant. Pitfalls in assessment of the drug concentration in milk to plasma (M/P) ratio are illustrated to expose errors in drug dose in milk estimates. Predictions about drug dose in milk must be confirmed by sampling of both milk and infant plasma for drug concentration. Principles for drug excretion in breast milk can be used as guidelines for excretion of a growing number of toxic agents.
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