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Monthly Archive for: ‘May, 2011’

Path Consulting1 E1311083108202

Value of Pathology Working Groups at EPL

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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 authority.  A review of the …

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