Introductory Concepts Flashcards

1
Q

true or false: a drug includes devices or their component parts or accessories

A

false

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2
Q

majority of drugs are of this chemical nature

A

weak acids and bass

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3
Q

majority of drugs available in the market are between ___ in size

A

10-1000 MW

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4
Q

the higher the generation, the more gram (-)/(+)?

A

(-)

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5
Q

This states that every physician should prescribe a drug in its generic name; the brand name is optional

A

Generic Act of 1988 (RA 6675)

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6
Q

[branch of pharma] involved in compounding, preparation, collection, standardization and dispensing of drugs (health service profession)

A

pharmacy

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7
Q

[branch of pharam] recognizing the drug; study of crude drugs and the identification of their sources

A

pharmacognosy

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8
Q

[branch of pharma] studies the structure activity relationship (SAR) of a drug

A

biochemorphology

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9
Q

Norepinephrine affects which receptors?

A

a1, a2, B1

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10
Q

Epinephrine affects which receptors?

A

a1, a2, B1, B2

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11
Q

Isoproterenol affects which receptors?

A

B1, B2

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12
Q

[branch of pharma] study of drug’s adverse effects

A

toxicology

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13
Q

how many tablets of paracetamol can be consumed per day before hepatotoxicity?

A

<8

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14
Q

antidote to Paracetamol poisoning

A

N-acetylcysteine

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15
Q

antidote to INH poisoning

A

pyridoxine

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16
Q

[branch of pharma] deals with dosage of drug needed to produce a therapeutic effect

A

posology

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17
Q

dosage usually given to elderlies and why

A

1/2 of adult dose because of slow metabolism

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18
Q

what to keep in mind when giving dosage in pedia

A

compute for dose for kg body weight

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19
Q

[branch of pharma] studies mechanism of action at the enzymatic level

A

molecular pharmacology

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20
Q

under molecular pharmacology, concerned with insertion, alteration, or removal of a gene to treat a disease

A

gene therapy

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21
Q

under molecular pharmacology, concerned with insertion of an artificial gene and making use of biotechnology to produce biopharmaceuticals that improve genetic make-up

A

genetic engineering

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22
Q

[branch of pharma] deals with drugs given to the mother as it affects the fetus

A

developmental pharmacology

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23
Q

true or false: there is no safe drug for pregnant women

A

true

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24
Q

ACE inhibitors can be given until which trimester only and why

A

until 1st trimester only because it inhibits urine production for the fetus

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25
Q

effect of isotretinoin on the fetus

A

mental retardation, cleft lip, ear and eye defect

26
Q

which vitamin could cause mental retardation in a fetus?

A

vitamin A (high dosage)

27
Q

[branch of pharma] considers influence of heredity on the effect of drugs

A

pharmacogenetics

28
Q

asians are fast or slow acetylators? and what does this mean?

A

FAST acetylators therefore drugs are more water soluble

29
Q

[branch of pharma] considers the use of genetic information to guide the choice of therapy or which drug variations produce certain response

A

pharmacogenomics

30
Q

[branch of pharma] studies response of a population to a drug and is used to detect and monitor adverse or beneficial effects

A

pharmacoepidemiology

31
Q

[branch of pharma] cost-effectiveness and follows rational use of drug (ESSC)

A

pharmacoeconomics

32
Q

[branch of pharma] studies interethnic differences in responses, presence of absence of enzymes, and comparing the use of traditional vs modern drugs

A

ethnopharmacology (pharmacoanthropology)

33
Q

[branch of pharma] deals with the rational development of drugs, and their safe and effective use and proper evaluation

A

clinical pharmacology (pharmacotherapeutics) / clinical or applied therapeutics

34
Q

ESSC Criteria

A

Efficacy, Safety, Suitability, Cost

35
Q

what BODY does to the drug/ fate of drug in the body

A

pharmacokinetics

36
Q

4 processes involved in pharmacokinetics

A

(ADME) Administration, Distribution, Metabolism, Excretion

37
Q

main distributor of the drug

A

blood

38
Q

major organ for metabolism of the drug

A

liver

39
Q

sites of absorption

A

stomach and SI

40
Q

major excretory organ

A

kidney

41
Q

other excretions via:

A

lungs, skin, bile, saliva

42
Q

route of pharmacokinetics

A

administration –> systemic circulation –> target organ –> effect

43
Q

what DRUG does to the body/ involves MOA (enzymatic or molecular level)

A

pharmacodynamics

44
Q

pharmacodynamics can be observed once drug reaches what point?

A

target area

45
Q

6 Stages of Drug Development

A

1) Animal Testing
2) FDA - file IND app
3) Clinical Testing (first 3 phases)
4) Product Development
5) New Drug Application
6) Post Marketing Surveillance (PMS) / 4th phase of clinical testing

46
Q

animal testing determines toxicity. Define acute, subacute and chronic toxicity

A

Acute: 7-14 days
Subacute: 2wks-3mos
Chronic: 6mos- 2yrs

47
Q

duration of animal testing

A

1-3 years

48
Q

safety review is conducted by the FDA for how long

A

30 days

49
Q

what application do u submit to the FDA before the drug can proceed to human clinical trials?

A

Investigational New Drug (IND) application

50
Q

duration of human clinical trials

A

2-10 years (ave: 5-6 yrs)

51
Q

phases of clinical testing

A

1 - safety
2- efficacy and dose
3 - verify efficacy and detect ADRs
4 - additional data after approval

52
Q

sample needed per phase of the clinical trial

A

1 - healthy adult (20-80)
2- selected patients (100-300)
3 - large sample of selected patients (1000-3000)
4 - general population?

53
Q

who conducts each phase of the clinical trial

A

1&2: clinical pharmacologist

3: clinical investigators
4: all physicians

54
Q

average time for product development

A

12 years

55
Q

how many compounds are evaluated, how many enter the trials and how many are approved?

A

5,000 compounds evaluated
5 enter trials
1 approved

56
Q

stage of drug development where additional data are obtained, as well as product defect reporting, product line extensions, and chronic effects

A

Post Marketing Surveillance (PMS)

57
Q

this is used to achieve blindness and subjective bias

A

placebo

58
Q

enhances or depresses NON-specialized tissues

A

irritation

59
Q

variables involved in drug activity

A

1) pharmaceutical phase (disintegration and dissolution)
2) pharmacokinetic phase (bioavailability)
3) pharmacodynamic phase (individual sensitivity, drug-drug interactions, pathological conditions)
4) Effects (toxic, therapeutic, subtherapeutic)

60
Q

refers to the fraction of the drug that remained unchanged reaching the systemic circulation

A

bioavailability

61
Q

bioavailability via IV vs orally; why?

A

IV: 100% (bypasses the liver)
orally: 5-10% (first-pass effect) synthetic or non-synthetic