The frequency and duration of sampling should be sufficient to accurately assess the outcome selected, e.g., estimate the relevant pharmacokinetic parameters for the parent drug and its metabolites (see Data Analysis section below). Samples should be collected in a manner to characterize the complete dosing interval. Each breast should be completely emptied at each sampling time, the volume of milk recorded, and an aliqout removed for analysis. An electric milk pump is recommended since milk composition can vary with the method used. Separate collection containers should be used for each milk collection. Pooling of different-timed milk samples is not recommended. Consideration should be given to sample handling and the protocol should include the precise details especially with milk samples (e.g., methods to minimize contamination). Total and unbound concentrations of drug and metabolites should be determined. Bioanalytical methods should determine drug and metabolite concentrations in all biological matrices studied (e.g., plasma, serum, whole blood, breast milk, urine). Milk samples should additionally be assayed for milk fat.
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