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Pharm Summer 1 > Exam 1 > Flashcards

Exam 1 Flashcards

1
Q

substances that change biological function (ie in a subject or an organism) through chemical action

A

drug

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2
Q

What is the definition of a drug?

A

A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease

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3
Q

What determines and regulates the drug approval process, language used on the label and on ads, enforces Public Health Service Act, and enforces the Federal Food, drug, and cosmetic act?

A

Food and Drug Administration (FDA)

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4
Q

What is the primary focus of the FDA?

A

Enforce the Federal Food, Drug and Cosmetic Act

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5
Q

Is drug regulation the same now as it was in the 80s?

A

No, drug laws are constantly changing and have not always been that way. Laws have evolved greatly and its because of the FDA

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6
Q

What are the four categories of drug development?

A

In vitro studies, animal testing, clinical testing and marketing

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7
Q

At this time, chemists and drug manufactures are thinking about what drug they want to develop, and editing compounds that they think they might want to be a drug

A

In vitro studies

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8
Q

Biological products and chemical synthesis of an optimal new drug is called the

A

lead compound

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9
Q

About how long does it take for chemists to come up with a drug to take to animal testing?

A

2 years

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10
Q

What. is the next stage after in vitro studies?

A

Animal testing

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11
Q

During the animal testing stage, what are the manufactures checking with the new drug?

A

Efficacy, selectivity, and mechanism–They want to make sure the drug is safe and see if it even helps whatever we are testing

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12
Q

From animal trials onwards, what are we always testing?

A

Safety assessment and drug metabolism

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13
Q

After about 2 years of successful animal trials, what must be done to move on to clinical testing?

A

Apply for an IND (Investigational New Drug) from the FDA

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14
Q

What is the first process in a chemical becoming a drug as far as the FDA is concerned?

A

IND

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15
Q

What are the phases of clinical testing

A

Phase 1, Phase 2, Phase 3

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16
Q

During clinical testing, this phase has about 20-100 subjects and is testing safety of the drug

A

Phase 1

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17
Q

During this clinical phase, the number of participants has increased to about 100-200 and it is testing safety and seeing if it actually works

A

Phase 2

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18
Q

This phase enrolls about 20-100 healthy people, usually college kids, typically without illness to make sure the drug is safe

A

Phase 1

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19
Q

What is the purpose of adding more people during each phase of clinical trials?

A

As you add more people, odds are if an adverse reaction is going to happen, it would more likely present itself in a larger number of enrollees

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20
Q

As clinicians, which phase do we typically start to hear about a drug?

A

Phase 3

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21
Q

What is the last stage of clinical trials before going to market?

A

phase 3

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22
Q

In this phase, number of participants is increased to 1000-6000 people, and double blind experiments are implemented, still concerned to see if the drug is actually working and if it is safe

A

Phase 3

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23
Q

What must a drug company apply for after successfully completing all three phases before going to market?

A

NDA (New drug application), usually happens after about 8-9 years after the drug was created within in vitro studies

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24
Q

Who approves the NDA before a drug goes to market?

A

FDA- reviews all clinical trials and approves marketing scheme; the drug companies have invested about 1 billion dollars at this point

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25
Q

What is phase 4 during drug development?

A

Marketing and postmarking surveillance

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26
Q

As a clinician, which phase are you required to report any adverse side affects of a drug you prescribed to the FDA?

A

Phase 4

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27
Q

How are drugs that have been on the market recalled after years?

A

Phase 4 post marketing surveillance, still monitoring safety forever

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28
Q

When does phase 4 end?

A

There is no end to phase 4, safety monitored forever

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29
Q

How do drug companies protect their product, having exclusive rights to what they have created?

A

Patents

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30
Q

How long do patents last and what happens when the patent period runs out?

A

Patents generally last about 20 years after filing. Drug companies typically apply for a patent right before the IND phase because people have to know the chemical makeup during that phase. So if it take 10 years to complete clinical phase, drug companies only have about 10 years to recuperate all their investment. After the 20 years, the drug can be made by any company as a generic

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31
Q

Can drug companies reapply for another patent once their time is up?

A

No, they can try to extend

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32
Q

What is FDA’s center of drug evaluation and research?

A

CEDR

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33
Q

What ensures drugs (both Rx and OTC) for use in humans to be marketed are safe and effective?

A

CEDR

34
Q

Some drugs that start as prescription eventually are deemed safe enough to see to public without provider, who makes this change?

A

CEDR

35
Q

Must be submitted before initiating human clinical trials, and provides exemption to federal law to allow transport across state lines for clinical trials

A

IND

36
Q

What all is an IND required for?

A

new indication, change in companies promotion, change in approved population or risk to population, change in approved route of administration or dosage

37
Q

What are the three types of IND?

A

Investigator, emergency use, and treatment

38
Q

This type of IND is used to initiate/conduct investigation

A

Investigator IND

39
Q

This type of IND authorizes use in emergency situations

A

Emergency IND

40
Q

This type of IND is for the use of drug showing promise in clinical testing for serious or life threatening conditions while final clinical trials are conducted

A

Treatment IND

41
Q

What information is required when applying for an IND?

A

animal pharmacology and toxicology studies, manufacturing/chemical information, and clinical protocols and investigator information

42
Q

Means by which drug sponsor formally proposes that the FDA approve a new pharmaceutical for sale and marketing in the US

A

NDA

43
Q

What information does FDA review to reach the decision about an NDA?

A
  • Drug is safe and effective in its proposed use
  • whether benefits outweigh the risks
  • proposed labeling is appropriate and what it contains
  • methods used in manufacturing maintain the drug’s quality and preserve the drug’s strength, identity, and purity
44
Q

Is it possible for a drug to be 100% safe?

A

No! There are zero drugs on the market that are 100% safe, wee always have to weigh benefits with the risks

45
Q

What is an ANDA?

A

Abbreviated new drug application

46
Q

This provides for the review of a generic drug product and is done after the patent of a drug runs out

A

ANDA

47
Q

What is the main focus a generic brand medication must demonstrate?

A

Bioequivalence- same chemical and same profile once in the body

48
Q

Do generic drugs have to go through human trials?

A

No

49
Q

Generic drugs must be comparable tot the innovator drug in what ways

A
  • dosage form (if original is tablet, it must also be)
  • strength
  • route of administration
  • quality
  • performance characteristics
  • intended use
50
Q

Why is it a faster process to make a generic form of a drug?

A

It is an “abbreviated” process because generally not required to provide preclinical and clinical date to establish safety and effectiveness

51
Q

What was the start of modern pharmaceutical market and extended the patent period and tied it to the length of the approval process

A

1984 Drug Price Competition and Patent Term Restoration Act

52
Q

Which phases are open label types of trials?

A

Phase 1 and Phase 4

53
Q

Which phase looks at efficacy, safety and dose ranging?

A

Phase 2

54
Q

Describes the chemical and molecular structure (Ex: N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine)

A

Chemical name

55
Q

Common name of a drug

A

generic name

56
Q

Brand name of a drug

A

trade name

57
Q

As a clinician, what drug name is important to know?

A

Generic and trade, but the most important is the generic name

58
Q

Who comes up the the generic name?

A

US Adopted Naming Council (USAN)

59
Q

Serves health professions of the United States by selecting simple, informative and unique nonproprietary names for drugs by establishing logical nomenclature classifications based on pharmacological and/or chemical relationships

A

USAN

60
Q

The discovering, chemistry, composition, identification, bio-physical effects, uses and manufacture of drugs

A

Pharmacology

61
Q

study of substances that interact with living systems through chemical processes (Activate to inhibit normal body processes)

A

Pharmacology

62
Q

the science of substances used to prevent and treat disease

A

medical pharmacology

63
Q

a branch of pharmacology that deals with poisons or drugs causing them

A

toxicology

64
Q

What the BODY does to a DRUG, how the drug MOVES?CHANGES in the body

A

Pharmacokinetics

65
Q

Relationship of adjustable elements (dose, form, frequency, route) to drug concentration

A

time profile in pharmacokinetics

66
Q

What does LADME stand for in pharmacokinetics?

A

Liberation (drug release)
Absorption (drug enters circulation)
Distribution (drug movement thru body “compartments”)
Metabolism (transformation of patent compound)
Elimination (drug removal from body)

67
Q

What the DRUG does to the BODY

A

Phamacodynamics

68
Q

Relationship of the drug concentration at site of action and magnitude of effect produced

A

Pharmacodynamics

69
Q

This type of Pharm includes physiologic effects of drugs (on the body, microorganisms, parasites, drug targets) and drug behavior at the site of effect

A

Pharmacodynamics

70
Q

The use of medicine in disease, evidence based medicine (1o, 2o, 3o literature, clinical trials), clinical guidelines and off-label uses

A

pharmacotherapy

71
Q

Variation in drug response due to variation in genes, includes drug receptors, targets, and transporters

A

pharmacogenomics

72
Q

what is most effected in pharmacogenomics?

A

metabolism

73
Q

this type of metabolizer has the highest serum drug concentration

A

Poor metabolizer

74
Q

this type of metabolizer has a “normal” or expected serum drug concentration

A

Extensive metabolizer

75
Q

this type of metabolizer has the lowest serum drug concentration

A

Ultra-extensive metabolizer

76
Q

What other properties are affected in pharmacogenomics?

A

Absorption, distribution, efficacy, and toxicity

77
Q

formulation, manufacture, stability, and effectiveness of pharmaceutical dosage forms

A

phamaceutics

78
Q

What branch of Pharm determines the appropriate route and formulation

A

pharmaceutics

79
Q

Metabolism is a ____ property

A

pharmacokinetic

80
Q

Drug interaction with a receptor is best describes as?

A

pharmacodynamics

81
Q

What must be filed prior to human clinical trials?

A

IND

Pharm Summer 1 (1 decks)

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