Dr. Barbara von Beust, one of CNE’s pathology experts, is co-author on a recently published paper in Toxicologic Pathology Special Issue, Contemporary and Emerging Applications in Clinical Pathology. In this paper, the principles of assessing adversity in toxicologic clinical pathology is being discussed. Here’s what she says about it:
It is a legal requirement that new compounds intended for therapeutic intervention in human beings are tested in animal trials for their potential toxicity or adverse effects. While the definition of a harmful (or adverse) effect may be relatively straight forward in anatomic pathology (eg presence of a particular lesion in a tissue such as heart, liver or kidney), the continuous character of clinical pathology data (eg hematology and clinical chemistry values) may sometimes be challenging for a final isolated interpretation of adversity. The article explaines and discusses why many clinical pathology variables must be assessed within a particular context (species, sex, study protocol, anatomic pathology changes, toxicokinetics, laboratory analytic concerns), requiring a profound understanding of normal and pathologic physiology as well as the inter-dependence of measured analytes and potential preanalytic and analytic artefacts, and that the isolated definition of an adverse effect based on laboratory data is the exception and not the rule.
You can access the paper here.