This document provides guidance on the non-clinical strategies to be considered when developing a drug product (both active substance and excipients) that will, or potentially could, come into contact with different sites of the body following normal clinical use, as well as after unintentional administration.
Studies on impurities arising from the active substances or excipients present in the drug product or extracted or leached from a container closure system are not covered by this guideline.
The principles outlined in this guidance should be applicable to all types of drug products, including biotechnology-derived pharmaceuticals and herbal products.