Histopathologic Peer Review (PR) is an important tool in aiding quality and accuracy in the histopathologic assessment of toxicology studies. The peer review verifies and improves the accuracy and quality of pathology diagnoses and interpretations. Pathology peer review is recommended when important risk assessment or business decisions are based on nonclinical studies. PR is important in large scale studies such as 1-year studies and carcinogenicity studies and in particular when there is significant human safety at stake or if a company making far reaching business decisions about a product; it is particularly important where carcinogenicity is a potential issue. It is a highly structured collaborative process and provides an independent, but highly expert, review of a designated subset of slides and the Study Pathologist’s microscopic diagnosis. The Study Pathologist and the PR pathologist work collaboratively to come to a consensus on the findings, if there are differences of opinion.
The contemporaneous Peer Review is performed by an experienced ACVP board-certified pathologist often with special expertise around the salient features of the study in consideration. The review includes assessment of a designated subset of slides as indicated by the OECD guidelines and the recommendations of the STP. It generally occurs before the pathology study is signed and the peer reviewed provides a certificate attesting to consensus. The certificate includes the list of tissues evaluated, data reviewed, and a signed declaration of consensus. The statement may be retained in the data or the in the final toxicology report.
Comparative Biosciences, Inc offers experienced Peer Review. We have a GLP validated pathology data acquisition system suitable for Peer Review, an experienced ACVP pathologist, a comprehensive document control system and a full time Quality Assurance Unit.
The Society of Toxicologic Pathologists (2010) Recommendations for Pathology
Peer Review Toxicologic Pathology Online first publication October 5, 2010
Morton D, Sellers RS, Barale-Thomas, E, et al: Recommendations for Pathology Peer Review. Toxicologic Pathology, 38: 1118-1127, 2010
OECD Series on Principles of Good Laboratory Practice and Compliance
Monitoring: No, 16, Advisory Document of the Working Group on Good Laboratory
Practice-Guidance on the GLP Requirements for Peer Review of Histopathology,
OEeD Publishing, Paris, Dec 2014.
The Society of Toxicologic Pathologists (2015) Review of the Organization for
Economic Co-operation and Development (OECD) Guidance on the GLP
Requirements for Peer Review of Histopathology. Toxicologic Pathology Online
first publication 24-Jul-2015, pp 1-8.