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 (min−max) | 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 |