Target Animal Safety for Veterinary Pharmaceutical Products

Since the passing of the Animal Medicinal Drug Use Clarification Act of 1994 and the creation of New Animal Drug Applications by the Food and Drug Administration Center for Veterinary Medicine, Target Animal Safety studies have been required to provide the evidence needed by regulatory officials to approve the use of these pharmaceuticals in animals. This chapter reviews the necessary parts of a Target Animal Safety study (e.g., standards, animals, route of administration, dose, dose, frequency and duration of administration, study design, observations and physical exams, clinical pathology tests, necropsy and histopathology examinations, statistical analysis, and study reports) and then explains parts that are different from standard safety assessments performed for human pharmaceuticals (e.g., statistics, prevention of bias, adverse events, etc.). The chapter ends discussing the importance of knowing the lab and their capabilities as well as providing “substantial evidence” and its importance in the design and reporting of a Target Animal Safety study.