ABSTRACT
For scientists involved in animal testing, it is necessary to design studies that generate the required safety assessment data and also satisfy the requirements of the various regulatory authorities which govern pharmaceuticals, agrochemicals and industrial chemicals. With a few notable exceptions, most regulatory authorities simply state the need for appropriate clinical pathology testing to be included without specifying exact requirements. Where individual tests are specified, a few may be considered inappropriate and scientifically unsound for use in animals. Several organizations (FDA, 1982; OECD, 1982; EPA, 1984; Malya et al., 1988; MHW, 1991) have suggested different test profiles to be performed in regulatory studies, and the definition and acceptance of such profiles by regulatory and professional bodies is an ongoing process. Two notable initiatives, one national and a second international, to improve safety assessment and standardize regulatory testing guidelines, have recently been undertaken. Alongside these initiatives are the wider attempts to achieve international harmonization of other aspects of toxicological studies.
