Regulatory Forum commentary: through the looking glass--SENDing the pathology data we have INHAND.
Toxicol Pathol
; 42(5): 807-10, 2014 Jul.
Article
em En
| MEDLINE
| ID: mdl-23599411
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.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Patologia
/
Sociedades Científicas
/
Toxicologia
/
Bases de Dados Factuais
/
Terminologia como Assunto
Tipo de estudo:
Guideline
/
Qualitative_research
Limite:
Animals
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Toxicol Pathol
Ano de publicação:
2014
Tipo de documento:
Article
País de afiliação:
Estados Unidos