Published on February 18, 2014
Experimental Pathology Laboratories, Inc. Pathology Peer Review
Reasons for Pathology Peer Review Ensure data meets requirements of regulatory agencies Increase accuracy of data Increase confidence in data Confirm target organs Confirm no effect level (NOEL)/ No adverse effect level (NOAEL) Ensure consistency of diagnoses within the study Continuing education
Pathology Peer Review • • • • Performed by a second pathologist Routinely performed by many companies May also be done to address specific issues Involves a subset of tissues from initial evaluation
Things a Peer Review is NOT • A re-read of a study • Does not generate a second data-set • A “blinded” re-examination • A performance review of the Study Pathologist
Third-Party Peer Review • Advantages of a third party peer review: – Independent – less likely to be perceived as exerting undue Sponsor influence – Often more experienced – may have seen similar changes with related compounds – Less of a threat to the Study Pathologist – changes to data often less contentious
Typical EPL SOPs • Rodents – Subchronic: • Complete Review (CR) of 20% of control and 60% of highdose groups • Targets: all animals, all dose groups • Proliferative changes: all animals, all dose groups – Chronic • Complete Review (CR) of 20% of control and 60% of highdose groups • Targets: all animals, all dose groups • Proliferative changes: all animals, all dose groups
Typical EPL SOPs • Dogs • Complete Review (CR) - 25% of control and 75% of highdose groups • Targets: all animals, all dose groups • Proliferative changes: all animals, all dose groups • Non-human Primates • Complete Review (CR) - 25% of control and 100% of highdose groups • Targets: all animals, all dose groups • Proliferative changes: all animals, all dose groups
Reconciliation • Following the review, the Study Pathologist and Reviewing Pathologist discuss all differences of opinion and arrive at a mutual consensus diagnosis • The Study Pathologist then modifies the data set and report as needed • The new data/report is reviewed by the Reviewing Pathologist • When the pathology report is finalized (signed), the Reviewing Pathologist signs the Peer Review Statement
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