ABSTRACT
The goal of this chapter is to review the hazard identification process in relation to excipients. Just as it is expected that every new active ingredient has to be tested to identify the potential hazards from its use in patients, so all the excipients used in the manufacture of the final drug product have to be shown to be safe for the purpose intended. A major difference between excipients and active ingredients is that the excipient is expected to be toxicologically inert. Thus, it would be expected that the excipient would have few or virtually no hazardous effects at the doses used. On the other hand, it is becoming more common for active ingredients to be discovered that present major problems in formulation to provide good pharmacokinetic profiles, and in these cases novel excipients may form a crucial function in permitting use of the drug, so that some hazard from the excipient may be identified.
