Test 1 part VI

Question 1

Federal food, drug, and cosmetic act of 1938

Answer 1

required that new drugs be safe as well as pure but did not require proof of efficacy

Question 2

the federal food drug and cosmetic act of 1938 was a response to what?

Answer 2

deaths associated with the use of a preparation of sulfanilamide marketed before it was adequately tested

Question 3

Kefauver Harris amedments of 1962 to the food drug and cosmetic act was in response to?

Answer 3

teratogenic drug disaster of thialidomide

Question 4

what is the role of the FDA

Answer 4

-oversees drug evaluation in the US and grants approval for marketing of new products
-responsible for aspects of food regulation in collaboration with the U.S. dept of agriculture

Question 5

how long do new drug clinical trials in human subjects take?

Answer 5

4-6 years

Question 6

T/F: new drug clinical trials are done concurrently with chronic safety testing in animals

Answer 6

true

Question 7

what all is required before a new drug can undergo clinical trials in human subjects?

Answer 7

1. informed consent of the patient
2. approval from FDA and IRB of the facility that is conducting the clinical trial

Question 8

Lifetime of a drug patent

Answer 8

20 years

Question 9

when does a patent “lifetime” begin?

Answer 9

at submission, which is usually after the drug screening phase.

Question 10

patent approval of a new drug can take __________ years or longer

Answer 10

5

Question 11

at what point can a generic version of a new drug be marketed by other pharmaceutical companies without fee or penalty

Answer 11

once the drug patent expires

Question 12

trademark drug name

Answer 12

is the drugs proprietary tradename
usually registered and may be legally protected

Question 13

diprivan is the ________________ name for propofol

Answer 13

trademark

Question 14

how many phases of clinical trials in human subjects are there?

Answer 14

4

Question 15

phase I of human clinical drug trials

Answer 15

1. determines the safe clinical dosage range
2. non-blind study
3. predictable toxicities are detected
4. uses 20-100 healthy volunteers
5. measurements of absorption, half-life, and metabolism are done

Question 16

what phase of human trials is the drug studied in patients with the target disease to determine its efficacy

Answer 16

phase II

Question 17

which phase of human drug trials has a high rate of failure?

Answer 17

phase II

Question 18

how many drugs move from phase II to phase III in human clinical trials

Answer 18

25%

Question 19

which phase of human control trials are conducted in a special research center by specially trained clinical pharmacologists

Answer 19

phase I

Question 20

which phase of human clinical trials are conducted in special clinical centers (like university hospitals)

Answer 20

phase II

Question 21

which phase of human drug trials is single blinded

Answer 21

phase II

Question 22

how many people are typically involved in a phase II human clinical trial

Answer 22

100 -200

Question 23

how many people are involved in phase III human clinical trials

Answer 23

1000’s (with the intended dz)

Question 24

what is the purpose of phase III human clinical trials

Answer 24

to confirm and safety and efficacy by minimizing erros caused by placebo effects

Question 25

what research technique is used in phase III human clinical trials

Answer 25

double blind and crossover

Question 26

which human clinical trial phase is the most expensive

Answer 26

phase III

Question 27

where are phase III human clinical trial performed

Answer 27

in the environment of treatment for the disease

Question 28

which phase of human clinical trails can the application be made to the FDA to take the drug to market (under normal conditions)

Answer 28

after phase III as long as results meet expectations.

Question 29

under what situation may the FDA approve controlled marketing of drug prior to completion of phase III trials

Answer 29

for serious diseases where there is an urgent need of pharmacological therapy

Question 30

under what situation may the FDA permit controlled marketing of a drug prior to completion of phase II trials

Answer 30

for life threatening diseases

Question 31

approximately ___________% of drugs in phase III human clinical trials are involved in early controlled marketing

Answer 31

50

Question 32

when do phase IV human clinical trials occur

Answer 32

after marketing approval

Question 33

which phase of human control trials is monitoring the safety of the new drug under actual conditions of use in large numbers of patients

Answer 33

phase IV

Question 34

what phase of human clinical trials may low incidence toxicities (1 in every 10,000) become apparent

Answer 34

phase IV

Question 35

how long does phase IV human clinical trials take

Answer 35

no fixed duration of time

Question 36

drug A has therapeutic index of 3 and drug B has a therapeutic index of 10, which drug is safer?

Answer 36

drug B

Question 37

an inactive precursor chemical that must be absorbed, distributed, and converted to an active drug is a ____________________

Answer 37

prodrug

Question 38

constitutive effect

Answer 38

basic functioning of receptors without any other additives to their functioning

Question 39

R(active) + R (inactive) will produce a _________________ effect

Answer 39

constitutive

Question 40

___________________ is the first of a complex sequence of steps in a drug producing an effect

Answer 40

drug binding

Question 41

what are two examples of how drug response and effect could be altered by changes in the components responsible for completing the DR complex

Answer 41

1. wrong diagnosis (giving abx for viral infection) 2. compensatory mechanism activity (kidney increase BP in presence of antihtn)

Question 42

changes in tissue or plasma binding can change the _______________ of a drug

Answer 42

volume of distribution

Question 43

abnormal accumulation of fluid (edema, ascites, pleural effusion) can markedly ________________ the volume of distribution of a drug

Answer 43

increase

Question 44

impairment in the function of which organs may cause abnormal clearance of a drug

Answer 44

liver kidney heart

Question 45

hepatic disease has been show to decrease ____________ and prolong ____________ of many drugs

Answer 45

clearance; 1/2 life

Question 46

__________________ will occur between absorption and elimination

Answer 46

biotransformation

Question 47

in what situation may a drug compound have a phase II biotransformation reaction before phase I for elimination?

Answer 47

if the compound naturally includes a functional group

Question 48

to decrease the effects of the variable and natural hx of most diseases in human trials of new drug, what should be done?

Answer 48

evaluate a large enough population of subjects over sufficient period of time and use cross over design

Question 49

the placebo response can contribute to what factor in human evaluation of a new drug

Answer 49

subject and observer bias

Question 50

a single blind study in human evaluation of new drug can be used to minimize _____________________

Answer 50

subject bias

Question 51

a double blind design study in human evaluation of new drug can be utilized to minimize _____________________

Answer 51

observer bias

Question 52

human clinical drug trials is governed by the ethical principles of the __________________

Answer 52

1966 declaration of helsinki

Question 53

what are the 3 components (in order) of G-protein signaling

Answer 53

1. Extracellular ligand is selectively detected by a cell-surface receptor which triggers the activation of G protein in the cytoplasm 2. the activated G protein changes the activity of an effector element (usually enzyme or ion channel) 3. the effector element changes the concentration of the intracellular 2nd messenger