ABSTRACT

Safety evaluation of pharmaceuticals, medical devices, food additives and chemicals is performed with a single goal in mind-to provide safe and effective products. Toxicology reports are written to supply regulatory authorities with the information required to make sound decisions regarding the risks and benefits of allowing these products to be marketed. Those employed to review these reports are not always toxicologists or pathologists. They may be unfamiliar with the type of investigation, the nature of the test compound or the types of adverse effects identified in the study. Therefore, it is of paramount importance that the results of a toxicology study and their interpretation are easy to follow. A “user-unfriendly” report is likely to irritate a reviewer, and an irritated reviewer is unlikely to develop a favorable opinion of the testing laboratory or the test compound.