ABSTRACT
INTRODUCTION The very title of this chapter poses an immediate semantic question as to the meaning of the term “non-clinical.” It is a misnomer in the sense that “clinical” by definition implies factual observation, and much of the information discussed in “nonclinical” assessment is based on observing how animals react to the administration of potential human medicinal compounds. Formerly, the term “preclinical” was used, but this, too, has similar etymological problems in that the timing of the studies in the development program is not always prior to first studies in humans.
