The role of clinical chemistry in chemical and drug safety evaluation by use of laboratory animals.

In the last decade, 149 new ethical drug entities have been placed in the hands of the American medical community (1). In each case the two critical determinants to the success or failure of each new compound as a viable product were safety and efficacy. Such data ultimately can only come from trials in patients. However, this must always be preceded by evaluations of safety in animals. It is the role of clinical chemistry in the assessment of drug safety in laboratory animals that is the subject of this commentary. There are many differences between the practice of clinical chemistry in a clinical setting and that practiced in drug-safety evaluation studies in industrial research. Although most clinical chemists think of the former category when discussing clinical chemistry, there are many clinical chemists who work in areas outside the hospital laboratory, including those who work in research environments concerned with the use of clinical chemistry in chemical and drug-safety evaluation. The many differences in analysis and interpretation of clinical biochemical data between these two areas of clinical chemistry will be highlighted in this discussion.