期刊
TOXICOLOGIC PATHOLOGY
卷 47, 期 2, 页码 100-107出版社
SAGE PUBLICATIONS INC
DOI: 10.1177/0192623318818790
关键词
whole slide imaging; digital pathology systems; regulatory toxicology studies; digital peer review; pathology peer review; validation; imaging chain
Whole slide imaging (WSI) technology has advanced to a point where it has replaced the glass slide as the primary means of pathology evaluation within many areas of medical pathology. The deployment of WSI in the field of toxicologic pathology has been delayed by a lack of clarity around the degree of validation required for its use on Good Laboratory Practice (GLP) studies. The current opinion piece attempts to provide a high-level overview of WSI technology to include basic methodology, advantages and disadvantages over a conventional microscope, validation status of WSI scanners, and perceived concerns over regulatory acceptance for the use of WSI for (GLP) peer review in the field of toxicologic pathology. Observations are based on the extensive use by AstraZeneca of WSI for the peer review of non-GLP studies conducted at Charles River facilities and represent the experiences of the authors.
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