INHAND 01: Non-rodent working groups - Update on the new terminology: Dog

Franck Chanut
Sanofi, Alfortville, France

The International Harmonization of Nomenclature and Diagnostic Criteria (INHAND) is a global project to review, update and harmonise diagnostic criteria and nomenclature for both proliferative and non-proliferative changes in laboratory animals. Manuscripts for the rodent terminology are almost finished or have been published. Non-rodent working groups (NRWG) have been established for the dog, NHP (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.

The NRWG for the dog consists of toxicologic and diagnostic pathologists from Japan, North America and Europe and the group has 20 members.

The NRWG for the dog is reviewing the applicability of the rodent nomenclature for this species and providing terminology unique for the dog, as well as determining when rodent terminology not appropriate for the species. This information is currently being written up and will be published with representative illustrations and references.

This session will present and discuss a selection of cases of particular relevance to the dog.

Membership of the dog NRWG: Jochen Woicke (Chair), Jean-Guy Bienvenu, Jessica Caverly Rae, Karyn Colman , John Cullen, Franck Chanut, Luc Chouinard, Wendell Davis, Ryo Fukuda, Maike Huisinga, Kai Kiyonori, Nicholas Macri, Heike-Antje Marxfeld, Emily Meseck, Kristen Nikula, Bhanu Singh, Kazutoshi Tamura, Michael Thibodeau, Enrico Vezzali, An Vynckie.


INHAND 02: Non-rodent working groups - Update on the new terminology: Minipig

Sean McKeag
Covance, Otley Road, Harrogate, UK

The International Harmonization of Nomenclature and Diagnostic Criteria (INHAND) is a global project to review, update and harmonise diagnostic criteria and nomenclature for both proliferative and non-proliferative changes in laboratory animals. Manuscripts for the rodent terminology are almost finished or have been published. Non-rodent working groups (NRWG) have been established for the dog, NHP (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.

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 NRWG for the minipig is reviewing the applicability of the rodent nomenclature for this species and providing terminology unique for the minipig, with particular focus on the Göttingen minipig, but also including lesions from the Yucatan, Sinclair and Hanford, as well as determining when rodent terminology not appropriate for the species. This information is currently being written up and will be published with representative illustrations and references.

This session will present and discuss a selection of cases of particular relevance to the minipig.

Membership of the minipig NRWG: Mikala Skydsgaard (Chair), Susanne Rittinghausen (GESC Liaison), Zuhal Dincer, Wanda Haschek, Kris Helke, Binod Jacob, Björn Jacobsen, Gitte Jeppesen, Atsuhiko Kato, Hiroaki Kawaguchi, Sean McKeag, Keith Nelson, Dirk Schaudien, Vimala Vemireddi, Zbigniew Wojcinski.


SEND 01: SEND update

Charlotte Keenan, Susanne Rittinghausen, Thomas Nolte

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 12 rodent organ 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, Female Reproductive System, Digestive System, Cardiovascular System and Skeletal System in the Journal of Toxicologic Pathology as supplements and on a web site – www.goReni.org.  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 assist with incorporating INHAND terminology as preferred terminology for SEND (Standard for Exchange of Nonclinical Data) submissions to the FDA.  Interest in utilizing INHAND nomenclature, based on input from industry and government toxicologists as well as information technology specialists, is encouraging wide acceptance of this nomenclature.