ABSTRACT

This chapter will review the safety evaluation strategy and conduct of toxicology tests for new pharmaceutical excipients administered by parenteral routes. Parenteral routes of administration to be discussed include intravenous (IV), intramuscular (1M), subcutaneous (SC), and intraperitoneal (IP). Less frequently used parenteral routes of administration for toxicology studies would include intrapleural, intra-arterial, intrathecal, and intracerebral. These routes of administration generally require anesthesia or surgical techniques to perform (1,2).