ABSTRACT

The formalization of the concept in clinical, pharmacological, and toxicological sciences, with the consequent development of unique terminology and conceptual models, is relatively recent. Biological measurements that can be classified as toxicologic biomarkers have been performed to some extent for many years. The “biomarker paradigm” as applied to the field of environmental epidemiology was initially defined in a 1987 US National Research Council (NRC) report. The NRC report also emphasized that the link between exposure and disease is likely to be a continuum of overlapping events rather than a series of distinct stages. The specific application of toxicity biomarkers in drug development, such as in lead selection and decisions to terminate compound development at an early stage, has also been addressed in a number of recent publications. The chapter also presents an overview of the key concepts discussed in this book.