ABSTRACT
Drug development is often divided into three distinct areas composed of (1) drug discovery with subsequent lead optimization, (2) nonclinical drug development, and, nally, (3) testing of the potential drug in clinical trials (Figure 2.1). The transition between these areas is a continuum and forms the basis of translational research and medicine. Importantly, the development of new drugs involves the evaluation of both animal model (nonclinical) and human (clinical) safety information. The drug development process is a highly regulated process in which specic regulatory agency criteria, including Good Laboratory Practice (GLP) regulations, must be followed (OECD 1998). GLPs apply to nonclinical studies conducted for the assessment of the safety or efcacy of chemicals (including pharmaceuticals) to man, animals, and the environment. GLPs help assure regulatory authorities and sponsors that the data submitted are a true reection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.
