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Pre-pharmacology > Chapter 2 (Drug design, testing, manufacturing and marketing) > Flashcards

Chapter 2 (Drug design, testing, manufacturing and marketing) Flashcards

1
Q

three names of drugs

A

chemical (used by manufacturers and chemists), generic (experts define the generic name), and trade (brand) name which only the company that developed it can use

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2
Q

Generic name

A

can be used by other companies once drug is off patent

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3
Q

trade name

A

only can be used by other companies if they buy the name rights from the original creator

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4
Q

benzodiazepine tranquilizers naming

A

all end with -am

ex. diazepam

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5
Q

diazepam

A

Valium; benzodiazepine

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6
Q

lorazepam

A

Ativan; benzodiazepine

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7
Q

midazolam

A

Versed; benzodiazepine

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8
Q

alprazolam

A

Xanax; benzodiazepine

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9
Q

Azmacort

A

treats asthma

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10
Q

Rythmol

A

treats cardiac dysrhythmias

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11
Q

Pepcid

A

treats peptic ulcer disease

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12
Q

Nasacort

A

corticosteroid nasal spray

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13
Q

Bronkaid

A

inhaled bronchodilator

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14
Q

Sudafed

A

pseudoephedrine

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15
Q

Cipro

A

ciproflaxacin

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16
Q

Premarin

A

estrogen compound from pregnant mares’ urine

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17
Q

Kaycel

A

made of potassium chloride

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18
Q

Elavil

A

elevates mood

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19
Q

Elimite

A

treatment for scabies mite

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20
Q

Flexeril

A

muscle relaxant

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21
Q

Nitro-bid

A

named for b.i.d which means twice a day

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22
Q

SR in drug name

A

slow release

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23
Q

Slow-K

A

slow release form of potassium

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24
Q

DS in drug name

A

double strength

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25
Q

Tylenol 4

A

Tylenol with 60 mg codeine/tablet

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26
Q

Tylenol 3

A

Tylenol with 30 mg codeine/tablet

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27
Q

Wycillin

A

Wyeth-Ayerst company penicllin

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28
Q

Wygesic

A

Wyeth-Ayerst company analgesic

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29
Q

Wytensin

A

Wyeth-Ayerst company med for high BP

30
Q

fluoroquinolones

A

quinolones that were modified with a fluoro group which made them better antibiotics

31
Q

Cipro

A

a fluoroquinolone

32
Q

Levaquin

A

a fluoroquinolone

33
Q

recombinant DNA technology drugs

A

first somatostatin, then HGH, but Insulin was the first to be sold

34
Q

most drugs are first found in nature but…

A

then modified to be even better

35
Q

animal trials reveal basic…

A

toxicology and pharmacokinetic information

ED50 and LD50 are found

36
Q

drugs in same classes have about the same…

A

LD50

37
Q

early clinical trials only use…

A

micro doses of drug

38
Q

proof of concept

A

just for drug company; it is used to convince higher ups to invest money into drug

39
Q

animal testing

A

done usually on animals selectively breeded to have the disease

40
Q

after in vitro and in vivo animal studies, if the drug warrants millions in further testing then…

A

an IND application is filed with the FDA (investigational New Drug); IND application allows company to transmit drug across state lines for testing

41
Q

in vivo studies

A

organ toxicity, addictive potential, side effects, teratogenicity

42
Q

Ames test

A

test for carcinogenic properties of drug in bacteria

43
Q

Drug patent

A

obtained after IND is granted (so before any clinical testing) and only lasts 17 years so companies hustle to get the most out of their patent before it becomes generic

44
Q

phase 1 testing

A

20-100 volunteers that are healthy
takes about 1 year
get information about pharmacokinetic properties and elimination methods of drug (pee, breathe, etc.)
very basic dosage (safe dosage explored but proper dose not set) and safety information

45
Q

phase 2 testing

A 
100-300 volunteers with disease
takes about 2 years
start getting efficacy data and some side effect data
therapeutic effect determined
determine correct dose for phase 3
46
Q

phase 3 testing

A

1000-3000 volunteers with disease
takes 2-4 years
test exactly how you plan to use the drug, so actual dose exactly

47
Q

cost to get drug through testing

A

about 1 billion

48
Q

drug patent extension

A

only last 17 years from IND, but up to 5 years can be given for certain things. 6 months is given for testing the drug on children for example.

49
Q

IND

A

investigational new drug

50
Q

Generic drugs need to have between…

A

75 and 125% of the brand name’s average mean drug level, but not necessarily bioequivalent

51
Q

orange book

A

lists all generic drugs bioequivalence

52
Q

ED50

A

effective dose 50%; half would benefit from this dose

53
Q

LD50

A

lethal dose 50%; half would die from this dose

54
Q

Therapeutic index

A

ratio of ED50/LD50; so high TI indicates effective treatment at low doses and lethal at high. Drugs with low TI must be monitored very closely (like digoxin)

55
Q

Bioavailability

A

the fraction of administered dose of medication that reaches systemic circulation; differences in bioavailability can be crucial

56
Q

bioavailability and bioequivalence

A

not the same thing; bioavail is just levels in circulation

57
Q

animal tests reveal

A

carcinogenic potential, TI (safe dosing ranges), bioavailability (binding of drug, absorption, blood levels,…all kinetic data)

58
Q

number of classic phases of drug human testing

A

3

59
Q

drug half life

A

T1/2: measures levels in blood, but drugs may not accumulate in blood so there may be build up somewhere and exert effect so pharmacological action of drug over time may not be reflected by half life

60
Q

side effects primarily determined…

A

phase 3 and 4 (postmarketing efforts of surveillance that are conducted after drug is approved by more data must still be collected). Rare side effects may not show up until thousands of people are taking the drug, so these cannot be determined until after phase 2.

61
Q

efficacy primarily determined

A

phase 2 and 3 (phase 3 really confirms its use because they are typically double blinded and have way more people)

62
Q

new drugs usually fail in phase 2 because…

A

lack of efficacy is found, but sometimes phase 3 must be stopped because of poor efficacy not discovered in phase 2 or new toxicity

63
Q

doubel blinded

A

used in phase 3, but sometimes cannot be used if it is dangerous to give placebo to patients

64
Q

generic and Rx drugs

A

have same active ingredients and are advertised in same way, but inert ingredients may be different (binders and fillers) which supposedly do not affect absorption and distribution of the drug

65
Q

generic substitution

A

allows prescriber to insist of specific trade name by writing no substitution or dispense as written, but people often have to fight insurance companies for it

66
Q

1985

A

FDA ruled that ads must list side effects

67
Q

1997

A

FDA ruled that reminder adds must list side effects

68
Q

top 10 TV drug commercials

A 
Cialis and Viagra
Lyrica for fibromyalgia
Eliquis (a blood thinner)
Celebrex (a selective cox 2 inhibitor)
Monoclonal antibody drugs
69
Q

phase 0

A

animal testing

70
Q

company must have IND and patent before…

A

NDA and phase 2 and 3

Pre-pharmacology (27 decks)

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