title: The north american control animal database: a resource based on standardized nomenclature and diagnostic criteria.
abstract: Historical control data have been shown to be valuable in the interpretation and evaluation of results from rodent carcinogenicity studies. Standardization of terminology and histopathology procedures is a prerequisite for meaningful comparison of control data across studies and analysis of potential carcinogenic effects. Standardization is particularly critical for the construction of a database that includes incidence data from different studies evaluated by pathologists in different laboratories. Standardized nomenclature and diagnostic criteria have been established for neoplasms and proliferative lesions. Efforts of the National Toxicology Program, the Society of Toxicologic Pathology (STP), and the Registry of Industrial Toxicology Animal-data (RITA) have led to a harmonized pathology nomenclature for the rat and the mouse. This nomenclature with detailed descriptions of lesions is available in publications by the STP and International Agency for Research on Cancer (IARC). A listing of these terms is available on the World Wide Web. Utilizing the model established by RITA and working with the International Life Sciences Institute (ILSI), companies with laboratories in North America formed a working group in 1994 to establish and maintain a database of neoplastic and proliferative lesions from control animals in carcinogenicity studies. The rationale for development of the North American Control Animal Database (NACAD), the factors that influence tumor incidence, operation of the database, and the benefits to be realized by using a standardized approach are discussed.
authors.affiliation: Adolor Corporation, Malvern, Pennsylvania 19355-9603, USA. ckeenan@adolor.com
authors.forename: Charlotte
authors.initials: C
authors.lastname: Keenan
authors.forename: Angela
authors.initials: A
authors.lastname: Hughes-Earle
authors.forename: Marvin
authors.initials: M
authors.lastname: Case
authors.forename: Barry
authors.initials: B
authors.lastname: Stuart
authors.forename: Stephen
authors.initials: S
authors.lastname: Lake
authors.forename: Charles
authors.initials: C
authors.lastname: Mahrt
authors.forename: William
authors.initials: W
authors.lastname: Halliwell
authors.forename: Richard
authors.initials: R
authors.lastname: Westhouse
authors.forename: Michael
authors.initials: M
authors.lastname: Elweee
authors.forename: Daniel
authors.initials: D
authors.lastname: Morton
authors.forename: Gerd
authors.initials: G
authors.lastname: Morawietz
authors.forename: Susanne
authors.initials: S
authors.lastname: Rittinghausen
authors.forename: Ulrich
authors.initials: U
authors.lastname: Deschl
authors.forename: Ulrich
authors.initials: U
authors.lastname: Mohr
mesh_terms: D000818:Animals; D000830:Animals, Laboratory / Q000502:physiology*; D016208:Databases, Factual; D051379:Mice; D010336:Pathology / Q000592:standards*; D051381:Rats; D012016:Reference Values; D015203:Reproducibility of Results; D009626:Terminology as Topic