SAFETY ASSESSMENT OF PHARMACEUTICALS - EXAMPLES OF INADEQUATE ASSESSMENTS AND A MECHANISTIC APPROACH TO ASSURING ADEQUATE ASSESSMENT

For a conventional organic new chemical entity (NCE) being developed a s a pharmaceutical, standard regulatory safety assessment studies are required. Early in development, an NCE should undergo a safety/benefit analysis to justify further development. This analysis is made easier and more effective when comprehensive nonclinical data are available. One of the most important aspects of nonclinical toxicologic studies is to provide information on absence of potential carcinogenicity in h umans. To avoid human exposures to potentially carcinogenic agents, ev en in early development of an NCE, the Decision Point Approach to carc inogen testing provides a useful guide to acquisition of mechanistical ly relevant data for risk assessment.