Dart (segment i,ii and iii)

Developmental and Reproductive Toxicity Studies, Toxicology

1. DART (segment I,II and III) AMIT KABEER Panjab university(UIPS)

2. WHAT IS ‘‘DART’’? DART- Developmental and reproductive toxicity. DART studies are performed to evaluate the potential effect of a given test item on reproductive performance of the parents and development of the offspring.

3. Fertility and Embryonic Development Study (Segment I) The test item is administered to animals (rat or mice) prior to mating (28/70 days in male and 14 days in females) through mating, and implantation in rat or mice. The purpose of this study is to quantify the effect on oestrous cyclicity, spermatogenesis, and fertility of parents, development of offspring and on male reproductive organ.

4. Fertility and Embryonic Development Study (Segment II) The test item is administered to the animals (rats or mice or rabbit) from the day of implantation to the closure of the hard palate. This study is providing the information concerning the effects of prenatal exposure on the pregnant test animal and on the developing foetus.

5. Pre-and Postnatal Study (Segment III) The test item is administered to animals (rat or mice) from the Gestation day 6 to Lactation day 21. The purpose of this study is to quantify the effect on late foetus development, the process of parturition, developmental (behavioural and functional) of offspring.

6. Juvenile Toxicity Study The design of Juvenile toxicity study is based on the age of paediatric population. The selection animal species, dose, dose duration and selection of appropriate endpoints are depending up on the targeted paediatric population. The juvenile toxicity study is required when human safety data and previous animal studies are insufficient for a safety evaluation in the intended paediatric age group or it should be performed on a case-by-case basis.

7. THANK YOU