lecture 8

Question 1

what are the steps of the drug development process?

Answer 1

in vitro studies for lead compound, then animal testing for efficacy selectivity and mechanism, next clinical testing, then marketing

Question 2

what are the three phases of clinical testing?

Answer 2

1= is it safe (pharmokinetics), 2= does it work,3 = does it work double blind?

Question 3

time from synthesis to approval is roughly how many years?

Answer 3

10

Question 4

what does IND do?

Answer 4

looks at composition, manufacturing, animal studies, clinical protocols, clinical investigators.

Question 5

what much happen before allowing drug to go into clinical trials?

Answer 5

FDA approval

Question 6

how many people used in phase 1?

Answer 6

20-80

Question 7

how many of drugs are approved after phase 1?

Answer 7

20%

Question 8

is phase 1 blinding or not?

Answer 8

not blinded

Question 9

how many people in phase 2?

Answer 9

100-200

Question 10

what percent of phase 2 are approved?

Answer 10

30%

Question 11

is phase 2 blinded?

Answer 11

single blinded

Question 12

which phase has placebo and active drug controls?

Answer 12

phase 2

Question 13

how many people are in phase 3 ?

Answer 13

about 5000

Question 14

which phase looks at side effects?

Answer 14

phase 3

Question 15

what percent of phase 3 drugs are approved?

Answer 15

70%

Question 16

NDA stands for what

Answer 16

new drug application

Question 17

what is approved by FDA as part of NDA process?

Answer 17

the label

Question 18

is the label a critical guide?

Answer 18

no

Question 19

what is phase 4?

Answer 19

additional trials that FDA may request. post marketing surveillance. detection of low incidence side effects <1 in 10,000

Question 20

what may result in black box warning or recall of drug

Answer 20

phase 4

Question 21

_______ must be obtained for clinical trial, even of approved drug

Answer 21

IND

Question 22

illegal to ship interstate for other than _______________.

Answer 22

label indication

Question 23

generic manufacturer must prove what?

Answer 23

bioequivalence of generic formulation

Question 24

demonstration of bioavailability is - or +_____ % of formulation?

Answer 24

20

Question 25

more complex studies required for generic protein therapeutics calls what?

Answer 25

biosimilars

Question 26

explain harrison narcotics acts of 1914?

Answer 26

regulation of production and use of narcotics. enforced by federal bureau of narcotics in treasury department, taxation of prescriber

Question 27

controlled substances act of 1970 purpose?

Answer 27

decrease availability of drugs to abusers

Question 28

controlled substances act of 1970 enforcers?

Answer 28

drug enforcement agency within department of justice, permits for dentists for fee

Question 29

chemicals categorized into schedules based on what 3 things?

Answer 29

abuse potential, pattern and significance of abuse, risk of dependence

Question 30

what is class 1 of controlled substances?

Answer 30

herion and marijuana

Question 31

what is class 5 of controlled substances?

Answer 31

etc with some limits

Question 32

what are class 3 and 4 of controlled substances?

Answer 32

limit to refills. 3=codeine. 4= BZD

Question 33

what is class 2 of controlled substances?

Answer 33

morphine and hydrocodone. no prescription refills