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4081751 
Book/Book Chapter 
Chapter 13: Endocrine Glands 
Greaves, P 
2012 
Elsevier Science 
Amsterdam, Netherlands 
Histopathology of preclinical toxicity studies: Interpretation and relevance in drug safety evaluation 
725–797 
English 
is a chapter of 2919080 Histopathology of preclinical toxicity studies: Interpretation and relevance in drug safety evaluation
This chapter provides an overview of species differences in the anatomy and physiology of the endocrine system among rodents, dogs and primates, emphasizing the differences in control systems that may influence the interpretation of drug-induced changes and their relevance for people. It describes and discusses the human relevance of drug-induced changes in the pituitary gland, adrenal cortex, adrenal medulla, follicular and C cells of the thyroid and parathyroid glands.

Notable changes in endocrine tissues in toxicity studies are various forms of atrophy, hypertrophy, hyperplasia and neoplasia as a result of perturbation in endocrine balance when high doses of potent therapies are administered. The difficulties in the histological distinction between hyperplasia, benign and malignant neoplasia in endocrine tissues is discussed.

This chapter reviews the likely relevance of such changes in the evaluation of the safety of drugs, particularly in long-term high dose studies in rodents. 
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