introduction

Question 1

Animal studies do not indicate risk & no controlled human studies OR animal studies do show harm, but well controlled studies in women do not

Answer 1

Category B

Question 2

Studies have shown teratogenic or embryocidal effects in animals, but no controlled studies in women OR no studies available in animals or women

Answer 2

Category C

Question 3

High potential for abuse; no accepted medical use

Answer 3

Schedule I

Question 4

High potential for abuse; currently accepted medical use

Answer 4

Schedule II

Question 5

Heroin

Answer 5

Schedule I

Question 6

Morphine

Answer 6

Schedule II

Question 7

Lesser potential for abuse

Answer 7

Schedule III-V

Question 8

All other prescription drugs

Answer 8

Schedule VI

Question 9

drug discovery

Answer 9

lab bench

Question 10

Pre-clinical

Answer 10

pharmacokinetics/ safety in animals

Question 11

Pharmacokinetics/ safety in small group of healthy adults

Answer 11

clinical phase I

Question 12

effectiveness in medium group of target population

Answer 12

clinical phase II

Question 13

randomized control trial with large group

Answer 13

clinical phase III

Question 14

NDA application

Answer 14

2 million, 0.5-2 yrs review time

Question 15

drug approval

Answer 15

15 years and 1 billion dollars to get one drug screened

Question 16

anything learned after approval. Drug can be prescribed for off-label use, but pharmaceutical companies cannot advertise drug for off-label use

Answer 16

Phase IV

Question 17

Genetics is a shorter process: just have to show same ______________ profile

Answer 17

pharmacokinetic

Question 18

1906 FDA

Answer 18

meat regulation

Question 19

1938 FDA

Answer 19

drug safety after antibiotics were dissolved in toxic ethylene glycol

Question 20

1962 FDA

Answer 20

thalidomide

Question 21

1992 prescription drug free user act

Answer 21

fee for NDA and faster review times

Question 22

1994 DSHEA

Answer 22

separate category for dietary supplements with little regulation

Question 23

A–>X

Answer 23

increasing fetal risk

Question 24

primary literature

Answer 24

phase 3

Question 25

secondary literature

Answer 25

phase 4

Question 26

original with less bias, but time consuming

Answer 26

primary lit

Question 27

easier-to-read but can be biased

Answer 27

secondary lit