ABSTRACT

The Anatomic Pathology section of a regulatory toxicology report contains information related to organ weight changes, necropsy findings and histopathologic evaluation. Depending on the objectives of the study (single-dose study, reproductive study, range-finding study, investigative study, etc.), some or all of these parameters may be excluded. Depending on your laboratory or company report-writing policy, the Anatomic Pathology section is either an integral part of the regulatory toxicology report or a separate report written as an annex and included as an appendix of the regulatory toxicology report. It may consist either of results with a discussion within each respective subsection (organ weight, necropsy, histopathology) of the narrative, or only the results-with an overall discussion of all results placed at the end of the toxicology report. The writing philosophy of this Guide is based on clarity of data presentation and interpretation, flow of ideas and a coherence of the logical relation between information from different sources; therefore, only examples of an Anatomic Pathology section which would immediately follow the Clinical Pathology section are presented here.