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Pharmacology I > Test 1 part VI > Flashcards

Test 1 part VI Flashcards

1
Q

Federal food, drug, and cosmetic act of 1938

A

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

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2
Q

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

A

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

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3
Q

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

A

teratogenic drug disaster of thialidomide

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4
Q

what is the role of the FDA

A

-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

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5
Q

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

A

4-6 years

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6
Q

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

A

true

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7
Q

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

A
  1. informed consent of the patient
  2. approval from FDA and IRB of the facility that is conducting the clinical trial
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8
Q

Lifetime of a drug patent

A

20 years

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9
Q

when does a patent “lifetime” begin?

A

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

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10
Q

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

A

5

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11
Q

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

A

once the drug patent expires

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12
Q

trademark drug name

A

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

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13
Q

diprivan is the ________________ name for propofol

A

trademark

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14
Q

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

A

4

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15
Q

phase I of human clinical drug trials

A
  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
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16
Q

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

A

phase II

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17
Q

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

A

phase II

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18
Q

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

A

25%

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19
Q

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

A

phase I

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20
Q

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

A

phase II

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21
Q

which phase of human drug trials is single blinded

A

phase II

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22
Q

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

A

100 -200

23
Q

how many people are involved in phase III human clinical trials

A

1000’s (with the intended dz)

24
Q

what is the purpose of phase III human clinical trials

A

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

25
Q

what research technique is used in phase III human clinical trials

A

double blind and crossover

26
Q

which human clinical trial phase is the most expensive

A

phase III

27
Q

where are phase III human clinical trial performed

A

in the environment of treatment for the disease

28
Q

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

A

after phase III as long as results meet expectations.

29
Q

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

A

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

30
Q

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

A

for life threatening diseases

31
Q

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

A

50

32
Q

when do phase IV human clinical trials occur

A

after marketing approval

33
Q

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

A

phase IV

34
Q

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

A

phase IV

35
Q

how long does phase IV human clinical trials take

A

no fixed duration of time

36
Q

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

A

drug B

37
Q

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

A

prodrug

38
Q

constitutive effect

A

basic functioning of receptors without any other additives to their functioning

39
Q

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

A

constitutive

40
Q

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

A

drug binding

41
Q

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

A
  1. wrong diagnosis (giving abx for viral infection)
  2. compensatory mechanism activity (kidney increase BP in presence of antihtn)
42
Q

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

A

volume of distribution

43
Q

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

A

increase

44
Q

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

A

liver
kidney
heart

45
Q

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

A

clearance; 1/2 life

46
Q

__________________ will occur between absorption and elimination

A

biotransformation

47
Q

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

A

if the compound naturally includes a functional group

48
Q

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

A

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

49
Q

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

A

subject and observer bias

50
Q

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

A

subject bias

51
Q

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

A

observer bias

52
Q

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

A

1966 declaration of helsinki

53
Q

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

A
  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

Pharmacology I (16 decks)

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