PHARMACOLOGY

 FEMALE REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDIES ::

These studies are to be carried out for all drugs proposed to be used in women of child bearing age Female fertility study is to be performed in albino mice or rats (segment 1) and developmental toxicity study is performed albino rabbits 

    on the occasion when the test compound is not compatible with the rabbit (e.g. antibiotics which are effective against gram positive anaerobic organisms and protozoas ) the Segment 11 data in the mouse may be substituted 

    Female fertility Study (Segment I): The study is done in one rodent species preferably rat The drug should be administered to both males and females beginning a sufficient number of days (28 days in males and 14 days in females ) before mating Drug treatment should continue during mating and subsequently during the gestation period Three graded doses are used The highest dose (usually the MTD obtained from previous systemic toxicity studies ) should not affect general health of the parent animals At least 15 males and 15 females should be used per dose group Control and the treated groups should be of similar size The route of administration should be the same as intended for therapeutic use 

    The animals are allowed to litter and their medication is continued till the weaning of pups observations on body weight food intake clinical signs of intoxication mating behaviour progress of gestation/parturition periods length of gestation parturition post-partum health and gross pathology (and histopathology of affected organs) of animals are recorded The pups from both treated and control groups are observed for general signs of intoxication sex wise distribution in different treatment group body weight growth parameters survival gross examination and autopsy Histopathology of affected organs should be done