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4081747 
Book/Book Chapter 
Chapter 11: Male genital tract 
Greaves, P 
2012 
Elsevier Science 
Amsterdam, Netherlands 
Histopathology of preclinical toxicity studies: Interpretation and relevance in drug safety evaluation 
615–666 
English 
is a chapter of 2919080 Histopathology of preclinical toxicity studies: Interpretation and relevance in drug safety evaluation
Histological examination of the male reproductive system is an important part of the assessment of new drugs before their first dosing to humans before specialist studies of reproductive function are performed.

This chapter provides an overview of the species differences in the anatomy and physiology of the prostate gland, other accessory sex glands and testis. It describes species differences in spermatogenesis and the techniques involved in the assessment of spermatogenesis. It describes pathologic alterations in prostate, accessory glands, testes and epididymis in rodents, dogs and primates in detail as these may reflect changes in hormone status as well as cellular toxicity. It addresses the issue of damage to germ cells in the testes in animal studies and likely relevance for humans. It provides an account of alterations to Sertoli cells and Leydig cells and an assessment of the general lack of relevance of Leydig cell tumors in the rodent testis for humans. The unique characteristics of mesotheliomas that are found in the mesothelial coverings of the testis particularly in the Fischer 344 rat and their general lack of relevance for human cancer hazard are also described. 
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