Doelemeyer, Arno, De Vera Mudry, Maria Christina, Kohler, Manfred and Schorsch, Frederic (2013) The CEPA* industry working group’s approach to image analysis based cell proliferation studies using electronic images. Toxicologic Pathology.

Abstract

Electronic images are increasingly used during the histopathology phase of toxicology studies, involving evaluations based on morphological changes for diagnosis, illustration, peer-review or reporting. In this paper we describe the approach of the European working group Cell Proliferation and Apoptosis (CEPA) for performing cell enumeration studies using electronic images. The Society of Toxicologic Pathology (STP) has published a position statement on handling of pathology image data in compliance with 21 CFR Parts 58 and 11. CEPA generally supports the STP position and shares the issues involved in the use of electronic images in pathology. However, considering the vast experience of members, particularly in conducting cell proliferation studies,, CEPA recommends that electronic images acquired using state-of-the-art slide imaging techniques, including whole slide scanning, need not be considered raw data, and therefore are not subject to 21 CFR Parts 58 and 11 regulations for archiving. In this paper, we detail the measures that are taken to ensure GLP-compliant execution of cell enumeration studies, including validation of imaging and image analysis systems and methods for their intended use and formulation and use of Standard Operating Procedures (SOPs).

Item Type:	Article
Keywords:	Cell proliferation, image analysis, toxicologic pathology, electronic data, archiving
Date Deposited:	28 Apr 2016 23:45
Last Modified:	28 Apr 2016 23:45
URI:	https://oak.novartis.com/id/eprint/6849