Reproductive toxicity studies are preclinical studies that are conducted to evaluate the potential adverse effects of a substance on reproductive functions and fetal development. These studies are typically conducted in laboratory animals, such as rats, mice, rabbits, or monkeys, to assess the safety of a drug or other substance before testing in humans.
The primary objective of reproductive toxicity studies is to identify any potential toxic effects of the substance on the reproductive organs, fertility, and fetal development. These studies can be further divided into three categories based on the exposure period and the endpoints evaluated:
- Fertility studies: These studies are conducted to evaluate the potential effects of the substance on reproductive function, including mating behavior, fertility, and reproductive performance of the male and female animals.
- Embryo-fetal development studies: These studies are conducted to evaluate the potential effects of the substance on fetal development during pregnancy. The studies involve administering the substance to pregnant animals during the gestation period and evaluating the potential effects on fetal growth, development, and viability.
- Perinatal/postnatal studies: These studies are conducted to evaluate the potential effects of the substance on the growth and development of offspring after birth. The studies involve administering the substance to pregnant animals and evaluating the growth, development, and behavior of the offspring after birth.
Reproductive toxicity studies typically involve the use of a range of doses of the substance and the evaluation of multiple endpoints, such as fertility parameters, reproductive hormones, fetal development, and histopathological examination of reproductive tissues.
Overall, reproductive toxicity studies provide valuable information about the potential risks of a substance to reproductive functions and fetal development, and can help inform decisions about the safety of the substance for use in humans.