The objective of ADME studies is to understand and characterise a medicine’s absorption, distribution, metabolism, and excretion. Although usually associated with Phase I, these studies may be performed throughout the development of a medicinal product. These studies are typically performed using a single dose in healthy males (n=4-6) using the intended route of administration.
The information gained from ADME studies is:
Distribution of parent medicine and metabolites in different body compartments (e.g. after crossing the blood-brain barrier)
Proportion of parent medicine converted into metabolite(s)
Primary mechanism(s) of elimination and excretion from the body