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Pathology for Toxicologists

Principles and Practices of Laboratory Animal Pathology for Study Personnel


Edited by Elizabeth McInnes








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List of Contributors

  1. Elizabeth McInnes
  2. Cerberus Sciences
    Thebarton, SA
  1. Natasha Neef
  2. Vertex Pharmaceuticals
    Boston, MA
  1. Cheryl L. Scudamore
  2. MRC Harwell, Harwell Science and Innovation Campus
  1. Bhanu Singh
  2. Discovery Sciences
    Janssen Research & Development
    Spring House, PA
  1. Barbara von Beust
  2. Independent consultant


Seemingly minor differences in opinion between the study pathologist and the study director or vice president of safety assessment (positions often filled by toxicologists) can escalate to cause real problems with the development of a test article in the pharmaceutical and agrochemical industries. Pathology is an imprecise science that relies on the observation of subtle variations in patterns of cellular arrangement and the tinctorial affinity of certain cells for staining procedures. Non-pathologists, such as toxicologists, can find it difficult to understand the data they receive from pathologists, partly due to the subjectivity of the discipline and the variations between pathologists, and partly due to the terminology that pathologists use.

There is a lack of pathological texts aimed at study personnel. This book has been written for toxicologists at all stages of their training or career who want to know more about the pathology encountered in laboratory animals, including study directors, study monitors, undergraduate and postgraduate toxicology students, toxicology report reviewers and research scientists employed in the pharmaceutical industry. The aim is to help study personnel bridge the gap in the understanding of pathology data. The book will enable them to understand the pathology reports they receive and the common pathologies encountered, so that they can more easily integrate pathology data into their final study report and ask pathologists relevant questions where there are gaps in understanding.

We have attempted to make the book user-friendly and easy to understand. Important lesions in rats, mice, non-human primates, mini pigs and beagle dogs, the most common laboratory animals used in the industry, are discussed. The compound-induced pathology in all the major organ systems is covered, as are clinical pathology, adversity and the limitations of pathology. There is also a glossary, which should help all non-pathologists understand the language of toxicological pathology. The aim is to demystify such terms as “chronic focal hepatic hypertrophy with Ito cell tumor.”

This book is intended to give study personnel an insight into the uncertainties encountered by the pathologist when reading studies and to provide them with explanations for why pathologists cannot always make up their minds. We trust it will improve communication and understanding between pathologists, toxicologists and study directors, so that a more succinct and helpful toxicologist report can be written.

Elizabeth McInnes