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2849993 
Book/Book Chapter 
Chapter 76 - Toxicologic pathology of the reproductive system 
Wanigikar, P; Ahmed, T; Vangala, S 
2011 
Academic Press 
San Diego, CA 
Reproductive and developmental toxicology 
1003-1026 
English 
is a chapter of 2849992 Reproductive and developmental toxicology
Summary
The adverse effects of a variety of environmental agents including environmental pollutants, drugs, cosmetics, agro-chemicals and pathogens on male and female reproductive systems are considered to be the major cause of infertility. The only assessment of male and female reproductive organs performed prior to the first administration of a novel pharmaceutical to humans is histopathological examination of sex organs in repeated dose toxicity studies in rodents and non-rodents. However, toxicity to the female reproductive system during pregnancy can result in teratogenicity with major deformities in organs in the offspring.

This chapter gives an overview of potential mechanisms, evaluation of endpoints of toxicity and induced histopathological lesions of male and female reproductive systems in laboratory animals along with toxicokinetics. This review also describes regulatory and non-regulatory studies that need to be carried out during drug development. Some examples of toxicants affecting reproductive and developmental systems are also provided. Current state-of-the-art understanding of the molecular mechanisms of teratogenesis with thalidomide as an example is also discussed. In conclusion, meticulous use of different methods of pathology can generate sufficient information for evaluation of the reproductive system during repeated dose toxicity and help to develop safer drugs for humans. 
1st 
Gupta, RC 
9780123820327