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Is the Lesion Adverse or Not?
Determining 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 […]
Value of Pathology Working Groups (PWG) at EPL
Although 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 […]