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Pharmacology > Exam 1: Drug Development & Testing > Flashcards

Exam 1: Drug Development & Testing Flashcards

1
Q

Drugs are chemical substances that are used for the _______, ________ or ________ of disease, and for the prevention of ________.

A

diagnosis, prevention or treatment….pregnancy

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2
Q

What was the first SPECIFIC drug used to treat an infectious disease (malaria) that was taken from nature?

A

Quinine

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3
Q

One of the first drugs was also called ‘the magic bullet’ which was SYNTHESIZED by adding ______ to carbon. It was used to treat syphilis.

A

arsenic

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4
Q

What is the drug from a plant that is still the best treatment for congestive heart failure? What plant is it from?

A

Digitalis from the Foxglove plant.

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5
Q

The isolation of _______ lead the way to techniques for the isolation of caffeine (thank God!), atropine, strychnine.

A

morphine

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6
Q

Atropine (to dilate the pupils) and Scopolamine (for motion sickness) are both derived from this plant….

A

Atropa BellaDonna

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7
Q

The SINGLE MOST IMPORTANT drug discovery in medicine.

A

ASA-Acetyl Salicyclic Acid (Aspirin)

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8
Q

What was the first hormone isolated? (Happened at Johns Hopkins)

A

Epinephrine

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9
Q

Penicillin was derived from this plant _______ and inhibited the growth of _______.

A

Penicillium Notatum……S. Aureus

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10
Q

What were the drugs that pre-date penicillin?

A

Sulfa Drugs

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11
Q

Sulfa Drugs are still used today to treat ______.

A

UTI’s

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12
Q

________ was the antibiotic used in WWII.

A

Penicillin

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13
Q

Time necessary to develop a drug is approximately ____ years

A

15 years

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14
Q

Cost of developing a drug approximates $____ million, but may cost significantly more.

A

$360 million

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15
Q

Only about ___ in 10 new compounds successfully reach the market

A

2 out of 10

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16
Q

How long is the patent on a NEW DRUG, when does that patent start?

A

17 years!! Clock starts at Phase 1 clinical testing (generally 8 year process!)

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17
Q

What are the 5 steps for Drug development? (Simplified!)

A

1.Discovery of a new drug 2.Safety evaluation 3. Effective in humans 4.New Drug Application 5.Post-market surveillance

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18
Q

Is Short-term toxicity testing done in humans or animals?

A

animals (generally mice)

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19
Q

The _______ is the dose of a drug that kills 50% of the total numbers of mice that received it.

A

Leathal Dose (LD50)

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20
Q

The _______ is the dose of a drug that causes an effect in 50% of the total numbers of mice that received it.

A

Effective Dose (ED50)

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21
Q

The margin of safety= ______ divided by ______.

A

LD50 / ED50

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22
Q

What is the margin of safety if LD50=10mg and ED50 = 2mg?

A

Margin of safety= 10mg (LD50) / 2mg (ED50) = 5

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23
Q

If a margin of safety is 5, that means the _______ is only 5 times the _______.

A

lethal dose is only 5x the effective dose

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24
Q

What is an ACCEPTABLE margin of safety for a drug?

A

2000 or MORE!!!

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25
Q

Long-term toxicity-aka ______ toxicity studies-give daily dosing to _____ or _____ from ___ months to ___ years.

A

chronic….rats or dogs….3months to 2 years

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26
Q

In long-term toxicity, many toxic effects appear only after repeated dosing over many ______ or ______. Also they _______ the animals to look at any histopathology.

A

months or years….sacrifice :(

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27
Q

Drugs that cause birth defects are termed ________.

A

teratogens

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28
Q

Studies for carcinogenicity of a drug typically rate over ____ months.

A

6

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29
Q

What is Submitted if drug has impressive margin of safety in mice, Submitted if drug lacks long-term toxicities, Submitted if drug does not cause cancer, reproductive effects or birth defects and is Usually a 30 day approval????

A

(IND)- Investigational New Drug Application

30
Q

The _____ is when the company releases information on the drug, including the chemical structure.

A

IND-Investigational New Drug Application

31
Q

When does Phase I clinical studies begin?

A

Immediately after IND(investigative new drug application) is approved

32
Q

Which testing Phase evaluates the drug in HUMANS for the first time?

A

Phase I…18-24 year old men (poor bastards)

33
Q

Phase I trials on healthy young men study the _____ profile, and determine the Pharmo______. It also establishes the dose at which ______ appears.

A

safety….pharmokinetics…toxicity (poor bastards!)

34
Q

Which Phase of testing do we give to patients with the condition for which the drug was intended?

A

Phase II

35
Q

About how many subjects are in Phase II trials? What time frame is this Phase studying? long-term or short-term?

A

100-300 subjects, studies SHORT-term effectiveness

36
Q

Which Phase studies adverse drug events?

A

Phase II, Phase III, Phase IV

37
Q

Which Phase establishes therapeutic efficacy, dose- response and dose range, kinetics, and metabolism.

A

Phase II

38
Q

Which Phase has 1000 to 3000 subjects?

A

Phase III

39
Q

Which Phase is checking long-term efficacy?

A

Phase III

40
Q

In Phase III-Trial design is always a ________, _______ control. So there are 2 groups, one receives the _____ and one receives the ______.

A

randomized, double-blind….drug, palcebo

41
Q

What is the MOST EFFECTIVE design for avoiding bias and distributing unknown variables between the treatment and control groups?

A

Randomized, double-blind control

42
Q

Phase ___ has one problem: small number of subjects taking drug for more than 3 to 6 months compared with the potential number who will take the drug long term

A

Phase III

43
Q

Phase III- Drug toxicities which occur at less than 1 in ____ exposures may not be revealed in this phase 3 trial! This is only found when ______ of people are taking the drug.

A

1 in 1000 exposures…millions!

44
Q

The _________ is submitted after 8 years of testing.

A

(NDA)-New Drug Application

45
Q

Phase IV is also known as _______.

A

Post-marketing Surveillance

46
Q

Phase IV can have the drug pulled off the market if new ______ are uncovered. Often problems in Phase IV result in _____ of the drug.

A

toxicities….relabeling

47
Q

The use of investigational drugs occurs during the review of _____. These are in rare situations and are considered “_______ use protocols”

A

NDA-new drug application (post/during? Phase III)..compassionate

48
Q

Who oversees OTC drugs?

A

FDA

49
Q

________– when a drug is being investigated by a company, it is identified by this name, which is determined by its chemical structure. If the structure is unknown, then usually a combination of ______ and _____.

A

Chemical Name…letters and numbers

50
Q

_______ – before any drug is marketed, it is given a this which becomes the “official” name of the drug (e.g. cola)

A

Generic name

51
Q

All drugs have one _______ name, but can have many ______ names

A

generic….brand

52
Q

generic names are NOT _______. ex. _______ is the generic name and Coumadin is the trade name.

A

capitalized…warfarin

53
Q

_______ - If the compound is found to be useful and will be marketed commercially, then the pharmaceutical company that discovered the drug gives the drug a this name (e.g. Coke)

A

Trade name

54
Q

Trade name = _____ name = Proprietary name

A

brand

55
Q

The 1984 – Drug Price Competition and Patent Term Restoration Act Allows ______ drugs to receive expedited approval.

A

generic (bastards!)

56
Q

The 1984 – Drug Price Competition and Patent Term Restoration Act: FDA still requires that the ________ of the generic product enter the bloodstream at the same rate as the trade name product.

A

active ingredient

57
Q

The 1984 – Drug Price Competition and Patent Term Restoration Act: _______ drugs are frequently more affordable and provide cost-savings to the patient

A

generic

58
Q

Prior to and at the start of the 20th century, tampering and mislabeling of food and drugs was common BUT! the 1906 – Pure Food and Drug Act came about, prompted by unsanitary and unsafe conditions in ______ industry.

A

meat packing

59
Q

How was the FDA created?

A

the 1906 Pure Food & Drug Act

60
Q

The 1906 Pure Food & Drug Act said that drugs must meet _______ of purity and quality AND manufacturers must provide correct and truthful ______.

A

standards…labeling

61
Q

the 1938 food, drug, and cosmetic act requiring proof of a drug’s safety and purity was brought about because the Lilly corp killed people by adding anti-freeze to their _____ drugs.

A

sulfa drugs

62
Q

The FDA Modernization Act of 1997 Allows drug manufacturers to discuss unapproved or “_______” indications with practitioners…. ________ drug approvals for life- threatening medical disorders…..Makes provisions for _______ drug research, Revises communications between FDA and researchers conducting ______ trials

A

“off-label”….accelerated..pediatric…clinical

63
Q

Durham-Humphrey Act of 1952 Grants the FDA authority to determine which drugs may be sold without a ________.

A

prescription (OTC)

64
Q

1962 Kefauver-Harris Amendments to the Food, Drug and Cosmetic Act Requires proof of ______ as well as _____ for new drugs and drugs approved since 1938.

A

efficacy as well as safety

65
Q

For dietary supplements, the FDA must demonstrate that a supplement is _____ before taking action against it.

A

unsafe

66
Q

________ cannot make therapeutic claims and must have the disclaimer: “this product is not intended to diagnose, treat, cure, or prevent any disease.”

A

Dietary Supplements

67
Q

An _____ disease is a disease that affects <200,000 people, there are incentives for manufacturers to develop drugs.

A

orphan

68
Q

Haha, before the Harrison Narcotic act of 1914 and Maryjane in 1937, these drugs were sold _____.

A

OTC!!

69
Q

Which government agency administers Controlled Substances?

A

DEA

70
Q

The _________ is an agreement between the FDA and the manufacturer so that the drug is presented in a way that is marketable

A

package insert

71
Q

Can the package insert for a drug contain bias?

A

YES!

Pharmacology (23 decks)

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