PHARMACOLOGY

 SPECIALIZED TOXICITY STUDY ::

These include fertility study carcinogenicity genotoxicity and teratogenecity etc 

Reproductive Toxicity ::

This includes male fertility female fertility and developmental toxicity studies 

Male fertility study ::

It is carried in one rodent species (preferably rat ) Dose selection is done from the results of the 14 or 28 day toxicity study in rat Three dose groups the highest one showing minimal toxicity in systemic studies and a control group are taken Each group consists of 6 adult male animals Animals should be treated with the test substance by the intended route of clinical use for minimum 28 days and maximum 70 days before they are paired with female animals of proven fertility in a ratio of 1:2 for mating 

    Drug treatment of the male animals should continue during pairing pairing should be continued till the detection of vaginal plug or 10 days whichever is earlier Females getting thus pregnant are be examined for their fertility index after day 13 of gestation All the male animals should be sacrificed at the end of the study Weights of each testis and epididymis are separately recorded Sperms from one epididymis are examined for their motility and morphology The other epididymis and both testes are examined for their histology