You are here:
STP WORKING GROUP FOR HISTORIAL DATA OF PROLIFERATIVE RODENT LESIONS
Citation:
KEENAN, C., S. ELMORE, S. FRANCKE-CARROLL, R. KEMP, R. KERLIN, J. PLETCHER, M. RINKE, S. SCHMIDT, I. TAYLOR, AND D. C. WOLF. STP WORKING GROUP FOR HISTORIAL DATA OF PROLIFERATIVE RODENT LESIONS. Presented at Society of Toxicologic Pathology Annual Meeting, Rio Grande, PR, June 10 - 14, 2007.
Impact/Purpose:
purpose
Description:
Abstract: The Historical Control Data Working Group, under the direction of the Scientific and Regulatory Policy Committee, is tasked with the preparation of a document that reviews current scientific practices, regulations and relevant literature in order to provide best practice recommendations for locating, generating and applying microscopic historical control data to current long term and carcinogenicity studies.
The working group is focused specifically on historical control data of neoplastic and proilferative lesions, used in the safety assessment of non-clinical rodent chronic toxicity and carcinogenicity studies.
The group is currently in the process of identifying, compiling and evaluating available sources of historical control data. A survey was undertaken in the international toxicologic pathology community including representation across pharmaceutical, chemical, and government regulatory institutions to assess current practices within the scientific community. The preliminary results are presented in this poster. The factors and variables which determine the reliability and usefulness of these data, relevant regulatory guidance and selected literature will be reviewed and published in Toxicologic Pathology.
This presentation does not reflect the policy or opinions of the US EPA or the US FDA