Abstract
The INHAND Proposal (International Harmonization of Nomenclature and Diagnostic Criteria for Lesions in Rats and Mice) has been operational since 2005. A Global Editorial Steering Committee (GESC) helps coordinate overall objectives of the project. Development of harmonized terminology for each rodent organ system or non-rodent species is the responsibility of the Organ Working Groups (OWG) or Non-rodent Working Groups (NRWG) respectively, drawing upon experts from North America, Europe and Japan.
Great progress has been made with 15 rodent organ systems published to date-Respiratory, Hepatobiliary, Urinary, Central/Peripheral Nervous Systems, Male Reproductive and Mammary, Zymbals, Clitoral and Preputial Glands and Hematolymphoid System in Toxicologic Pathology and the Integument and Soft Tissue, Female Reproductive System, Digestive System, Cardiovascular System, Skeletal System, Special Senses and Endocrine System in the Journal of Toxicologic Pathology as supplements and on a web site-www.goReni.org. Recommendations of the Apoptosis/Necrosis Working Group have been published. There are 5 non-rodent working groups-non-human primate, dog, minipig, rabbit and fish-with draft manuscripts in progress. A new group has been formed to address terminology in non-rodent ocular toxicity studies. A comprehensive review of all rodent systems to standardize terminology common to organ systems was completed and terminology updated in goRENI. INHAND guides offer terminology, diagnostic criteria, differential diagnoses and guidelines for recording lesions in toxicity and carcinogenicity studies. The guides provide representative photo-micrographs of morphologic changes, information regarding pathogenesis, and key references.
INHAND GESC representatives attend meetings with representatives of FDA Center for Drug Evaluation and Research (CDER), Clinical Data Interchange Standards Consortium (CDISC), and National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS) to assist with incorporating INHAND terminology as preferred terminology for SEND (Standard for Exchange of Nonclinical Data) submissions to the FDA. Interest in INHAND nomenclature, based on input from industry and government scientists, is encouraging wide acceptance of this nomenclature.
