Exam 3 toxicity and development

Question 1

accessibility refers to

Answer 1

FDA evaluates benefits/risks for the population

Question 2

applicability refers to

Answer 2

provider evaluates benefits/risks for a patient

Question 3

acceptability refers to

Answer 3

patient evaluates benefits/risks in terms of personal values

Question 4

what elements are required for IND

Answer 4

animal pharmacology and toxicology, manufacturing info, clinical protocol and investigator info

Question 5

how many steps are there to predict the first dose in man for a new drug

Answer 5

4

Question 6

what is step 1 to predict first dose

Answer 6

determine the maximal No Observable Adverse Effect Level in appropriate animal species

Question 7

what is step 2 to predict first dose

Answer 7

calculate human equivalent dose from appropriate species

Question 8

what is step 3 to predict first dose

Answer 8

determine a safety factor usually 10

Question 9

what is step 4 to predict first dose

Answer 9

divide human equivalent dose by safety factor to determine the maximum recommended starting dose

Question 10

do animal studies predict human responses

Answer 10

imperfect but not irrelevant/ most of the time they are correct

Question 11

what are acute stidies

Answer 11

effect of single dose at lease 2 species

Question 12

what are repeated dose studies

Answer 12

length depends on anticipates therapy at least 2 species

Question 13

what is genetic toxicity

Answer 13

determine likelihood cmpd is mutagenic or carcinogenic

Question 14

what is reproductive toxicity

Answer 14

needs depends on target population multiple species

Question 15

what is carcinogenicity

Answer 15

only for cmpd used in chronic or recurring conditions