Lec 9

Question 1

what are some instances where carcinogenicity studies are not needed?

Answer 1

Pharmaceuticals with dosing <6 months
life expectancy in <2 - 3 years
Replacement therapy (administering bodily substances to normal levels)

Question 2

what are some instances where carcinogenicity studies should be carried out?

Answer 2

structure-activity suggests carcinogen risk
generation of non-cancerous lesions in repeated exposure studies
long-term tissue retention

Question 3

how should a carcinogenicity study be carried out?

Answer 3

rat or mouse model subjects

Dose at MTD (Maximum tolerated dose where toxicity begins being displayed)

duration of 24 months (2 years)

Question 4

when do drugs have to undergo reproductive and developmental studies?

Answer 4

If women of childbearing potential can consume the drug (regardless if they’re pregnant)

Question 5

what are the 3 segments of reproductive / developmental toxicity studies?

Answer 5

Segment I - fertility and general reproductive performance
Segment II - Teratology (fetus) or embryo-fetal studies
Segment III - perinatal and postnatal development (last trimester of pregnancy and lactation period)