Chapter 1:Introduction and Overview

It is becoming increasingly critical to identify potential toxicities early in the development of new chemical entities, be they for the pharmaceutical or chemical industries. Our current approaches have limitations and the utility of animal data may not always ensure the safety of a chemical or pharmaceutical in humans. Predictive toxicology is often thought of in terms of in silico computational approaches. However, the concept of predictive toxicology has broader implications and in this context the chapters in this book discuss in silico, in vitro, and in vivo approaches that are being developed and applied in regard to toxicity prediction, and how these approaches may be integrated into modeling and simulation approaches for human hazard and risk assessment. Ultimately, it will be how we use and evaluate all of the data and approaches that will assist in making the breakthrough that is needed in assessing risks and improving the human safety of chemicals, and thereby reducing attrition of drug candidates due to safety issues and the potential human health hazards associated with chemical exposures. The various chapters in this book also reflect the growing need for improvements in our technologies and abilities to predict the toxicities of pharmaceutical and industrial chemicals to ensure product safety and the protection of public health. It brings together leading experts in the fields of toxicology and risk assessment to discuss their views on the current status of toxicity prediction as well as their visions of the future needs and challenges.