Fig. 2: Summary of FDA 2019 draft guidance for lactation studies, with some additional author reflections.
From: Clinical lactation studies. Acting on key recommendations over the last decade
Cmax maximum observed concentration, EID estimated infant dose, FDA Food and Drug Administration, M:P milk:plasma, PK pharmacokinetic(s), RID relative infant dose, Tmax time to maximum observed concentration, WOCP women of childbearing potential.
