Author name: kcahill@epl-inc.com

Reading Time: 3 minutesThe eye and the ocular adnexa are common target organs in toxicology studies, but the appropriate evaluation of ocular tissues is a specialized endeavor.  Compared to routine toxicity studies, ocular toxicity studies require methodological modifications at almost every stage from study design to the final pathology report. For example, at necropsy, the fragile nature of […]

Reading Time: 3 minutesA Pathology Working Group (PWG) is a specialized type of review composed of a group of expert pathologists convened to answer specific questions and provide an independent unbiased opinion regarding study results. They may be convened by study sponsors, consortiums, or government agencies. Members of the PWG may come from academia, government, or industry and

Reading Time: 2 minutesThe main purpose of a Pathology Peer Review is to improve the quality of the pathology data and narrative.  This can be achieved in several ways.  A peer review can help to ensure that the data are presented in a manner that meets the requirements of the regulatory agency to which the data will be

Reading Time: < 1 minuteDetermining whether or not a pathologic finding should be regarded as adverse has posed a conundrum for histopathologists for longer than I have been in the business. Much of the problem stemmed from the lack of a workable definition of adverse that could be useful to the pathologist and toxicologist and also acceptable to regulatory

Reading Time: < 1 minuteAlthough a Sponsor can never know exactly how a regulatory authority will respond to toxicity data, there are great examples of how a Pathology Working Group (PWG) can be beneficial.  Recently, the study pathologist for a mouse carcinogenicity study identified a relatively low number of renal tumors that raised the concern of the involved regulatory