Pathology raw data in nonclinical laboratory studies for the pharmaceutical industry: The pathologists' view

Post-mortem pathology data from nonclinical laboratory studies contain critical information for characterizing a new drug's safety and are pivotal for gaining an appreciation of potential hazards to humans. An understanding of the historical regulatory and scientific perspective on the nature of pathology data is valuable for assuring appropriate and useful audits of pathology material within nonclinical studies. This discussion reviews the specialty of pathology, the process of medical diagnosis, the definitions of ‘raw data’ as they pertain to histopathology data, and the rationale behind the consensus decisions made by industry and the Food and Drug Administration (FDA) in interpreting good laboratory practice (GLP) regulations for this type of data. Copyright © 2004 John Wiley & Sons, Ltd.