International Harmonization of Nomenclature and Diagnostic Criteria (INHAND) for Lesions in the Minipig.

ABSTRACT

The International Harmonization of Nomenclature and Diagnostic Criteria (INHAND) is a global project establishing diagnostic criteria and nomenclature for both proliferative and nonproliferative changes in laboratory animals. Nonrodent working groups (NRWGs) have been established for the dog, nonhuman primate, minipig, and the rabbit. The Global Editorial and Steering Committee (GESC) oversees the activities of the INHAND projects and is composed of toxicologic pathologists from all of the participating societies. In 2012, INHAND GESC began a collaboration with the U.S. Food and Drug Administration (USFDA) in adapting INHAND terminology for standardized nonclinical data submission to the FDA. The Standard for Exchange of Nonclinical Data is an implementation of the Clinical Data Interchange Standards Consortium Study Data Tabulation Model for nonclinical studies. The NRWG for the minipig consists of toxicologic and diagnostic pathologists from Japan, North America, and Europe, and the group has 15 members including a GESC representative. The NRWGs are reviewing the applicability of the rodent nomenclature for the species and providing terminology unique for the species as well as determining rodent terminology not appropriate for the species. This information will be published with representative illustrations and references.