title: International Harmonization of Nomenclature and Diagnostic Criteria (INHAND) progress to date and future plans.
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) manages the overall objectives of the project and the development of harmonized terminology for each organ system is the responsibility of the Organ Working Groups (OWG), drawing upon experts from North America, Europe and Japan.Great progress has been made with 9 systems published to date - Respiratory, Hepatobiliary, Urinary, Central/Peripheral Nervous Systems, Male Reproductive and Mammary, Zymbals, Clitoral and Preputial Glands in Toxicologic Pathology and the Integument and Soft Tissue and Female Reproductive System in the Journal of Toxicologic Pathology as supplements and on a web site - www.goreni.org. INHAND nomenclature guides offer diagnostic criteria and guidelines for recording lesions observed in rodent toxicity and carcinogenicity studies. The guides provide representative photo-micrographs of morphologic changes, information regarding pathogenesis, and key references. During 2012, INHAND GESC representatives attended meetings with representatives of the FDA Center for Drug Evaluation and Research (CDER), Clinical Data Interchange Standards Consortium (CDISC), and the National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS) to begin incorporation of INHAND terminology as preferred terminology for SEND (Standard for Exchange of Nonclinical Data) submissions to the FDA. The interest in utilizing the INHAND nomenclature, based on input from industry and government toxicologists as well as information technology specialists, suggests that there will be wide acceptance of this nomenclature. The purpose of this publication is to provide an update on the progress of INHAND.
authors.affiliation: C.M. Keenan ToxPath Consulting, Doylestown, PA, USA.
authors.forename: Charlotte M
authors.initials: CM
authors.lastname: Keenan
authors.affiliation: Charles River, Frederick, MD, USA.
authors.forename: Julia F
authors.initials: JF
authors.lastname: Baker
authors.affiliation: Charles River, Tranent, Scotland, UK.
authors.forename: Alys E
authors.initials: AE
authors.lastname: Bradley
authors.affiliation: Independent Consultant, Potomac, MD, USA.
authors.forename: Dawn G
authors.initials: DG
authors.lastname: Goodman
authors.affiliation: The Institute of Environmental Toxicology, Joso-shi, Ibaraki, Japan.
authors.forename: Takanori
authors.initials: T
authors.lastname: Harada
authors.affiliation: NIEHS, Research Triangle Park, NC, USA.
authors.forename: Ronald
authors.initials: R
authors.lastname: Herbert
authors.affiliation: Merck KGaA, Darmstadt, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Kaufmann
authors.affiliation: Fraunhofer ITEM, Hannover, Germany.
authors.forename: Rupert
authors.initials: R
authors.lastname: Kellner
authors.affiliation: NIEHS, Research Triangle Park, NC, USA.
authors.forename: Beth
authors.initials: B
authors.lastname: Mahler
authors.affiliation: Novartis Institute for Biomedical Research, East Hanover, NJ, USA.
authors.forename: Emily
authors.initials: E
authors.lastname: Meseck
authors.affiliation: Boeringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Nolte
authors.affiliation: Fraunhofer ITEM, Hannover, Germany.
authors.forename: Susanne
authors.initials: S
authors.lastname: Rittinghausen
authors.affiliation: Eli Lilly & Company, Indianapolis, IN, USA.
authors.forename: John
authors.initials: J
authors.lastname: Vahle
authors.affiliation: Department of Pathology II, Kansai Medical University, Hirakata, Osaka, Japan.
authors.forename: Katsuhiko
authors.initials: K
authors.lastname: Yoshizawa
keywords: regulatory science; rodent; terminology; toxicologic pathology