The primary objective of the study in lactating women should be clearly stated, for example, to determine if the PK and/or PD are altered in lactating women such that dose adjustment is necessary. Careful consideration should be given to adequate baseline determinations and comparisons to baseline. For example, for studies that are conducted to evaluate the effect on milk production (e.g., the quality or quantity of breast milk), the diurnal variation of milk production and composition should be considered in study design. Study design (e.g., participant selection, number of study subjects, sample collection) will vary according to the primary study objective.
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