ABSTRACT
The preclinical assessment of the safety of potential new pharmaceuticals and devices represents a special case of the general practice of toxicology possessing its own peculiarities and special considerations, and differing in several ways from the practice of toxicology in other fields-for some significant reasons.1^ Because of the economics involved and the essential close interactions with other activities (e.g., clinical trials, chemical process optimization, formulation development, regulatory reviews, etc.), the development and execution of a crisp and flexible, yet scientifically sound, program is a prerequisite for success. The ultimate aim of preclinical safety or biocompati bility assessment also makes them different. A good safety assessment program seeks to efficiently and effectively move safe, potential therapeutic agents or devices into, and support them through, the clinical evaluation, then to registration, and finally, to market. This requires the quick identification of those agents that are not safe so that effort (and limited resources) are not wasted on them.
