ABSTRACT
The fascinating challenge of drug discovery and drug development to the toxicologist is that drugs are designed to have a speci˜c biological function(s) that provides ef˜- cacy in human disease but which maintains a positive risk-bene˜t pro˜le for the patient. Thus, drug development is necessarily based on an informed, scienti˜c, and (ideally) a mechanistic understanding of toxicity and ef˜- cacy. Furthermore, the set of nonclinical studies which support development of a drug are speci˜cally tailored to support clinical trials for a particular treatment regimen, disease indication, and patient population. Pharmaceutical research and development (R&D) represents a somewhat specialized ˜eld of R&D in that effects in humans are studied directly using careful and controlled study designs. Therefore, clinical trial results are well suited to evaluate concordance between animal models and human subjects.
