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. 2014 Oct 7;79(4):558–565. doi: 10.1111/bcp.12524

Table 1.

Quality checklist based upon the FDA and ILCA protocol

Subject Criterion
Publication status No criterion: Registered type of study: full article, case report / letter or abstract
Study design
Median number of patients (minmax) No criterion: Registered number of included patients (and of which milk samples were obtained)
Longitudinal design Obtained milk samples at multiple days post-partum in same patient
Amount of drug in breast milk
Dose Daily dose of patient is given
Timing of dose Time between drug intake and milk sampling is given
Milk samples Obtained pre- and post-feed samples OR total milk collection of one feeding and took aliquot for analysis
Determination of kinetics
Milk concentrations Obtained at least five milk samples in one dose interval
Plasma concentrations Obtained at least five plasma samples in one dose interval
Active metabolites Measured active metabolites, if any
Infant plasma Obtained one plasma sample from nursed infant
Endpoints
Milk : plasma ratio (M : P) Correctly assessed if M : P is calculated from AUC in milk and plasma based on ≥ 5 milk and plasma levels
Absolute infant dose (AID) Correctly assessed if entire volumes of milk in 24 h were collected OR by collecting ≥ five milk samples in dose interval