Regulatory Forum Commentary: Through the Looking Glass—SENDing the Pathology Data We Have INHAND

Charlotte M. Keenan, Dawn G. Goodman

Research output: Contribution to journalArticlepeer-review

Abstract

During 2011, International Harmonization of Nomenclature and Diagnostic Criteria for Lesions in Rats and Mice (INHAND) Global Editorial Steering Committee representatives had discussions with representatives of the Food and Drug Administration (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 examine the potential use of INHAND 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 INHAND nomenclature. The purpose of this article is 2-fold: (1) to provide a brief historical background on the development of SEND and how it is structured and (2) to discuss the impact of SEND on toxicologic pathology and the role of INHAND.

Original languageEnglish (US)
Pages (from-to)807-810
Number of pages4
JournalToxicologic pathology
Volume42
Issue number5
DOIs
StatePublished - Jul 2014

Keywords

  • nomenclature
  • preclinical research and development
  • regulatory affairs

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Molecular Biology
  • Toxicology
  • Cell Biology

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