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Systemic Pharm I > Intro > Flashcards

Intro Flashcards

1
Q

What is pharmacology?

A

the study of substances that alter bodily functions when introduced into an organism

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2
Q

What did people do medically in ancient times?

A

pain and diseases were treated with different plant and animal extracts

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3
Q

When did the science of drug preparation begin?

A

17th century

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4
Q

When was the concept of controlled clinical trial introduced?

A

~60 years ago

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5
Q

What is the present focus of drug research?

A

drug receptors (substrate)

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6
Q

What is the future of drug research?

A

study of genetic makeup and individual response to specific drugs aka pharmacogenomics

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7
Q

T/F all substances can be toxic under certain circumstances

A

true

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8
Q

T/F all medications have side-effects

A

true, but not every patient will experience every side effect

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9
Q

What ratio is evaluated when considering a new drug for a patient?

A

the risk/benefit ratio

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10
Q

T/F all OTC products are regulated to the highest standard

A

false

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11
Q

Define a drug

A

any substance that alters body function when introduced into a living organism

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12
Q

What does a drug effect?

A

a specific target molecule (receptor)

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13
Q

What does a drug effect depend on?

A

size, electrical charge, shape, and atomic composition

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14
Q

What is pharmacodynamics?

A

the actions of the drug on the body aka effects at the receptor and the results

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15
Q

What is pharmacokinetics?

A

the actions of the body on a drug aka absorption, metabolism and excretion how the drug gets into and out of the body

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16
Q

What is an agonist?

A

binds to and activates a receptor

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17
Q

What are the two types of agonists?

A

full and partial

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18
Q

What is an antagonist?

A

prevents other molecules from binding to a receptor

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19
Q

What are the two types of antagonist?

A

reversible or irreversible

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20
Q

What is the principle behind administration/absorption?

A

the intended site of drug action must be reachable by the drug

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21
Q

What is the principle behind metabolism?

A

a drug may reach its intended target as an active molecule or it might require conversion prior to being active (prodrug)

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22
Q

What is the principle behind distribution?

A

most often a drug is administered into one body compartment and must move to the intended site of action

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23
Q

What is the principle behind elimination?

A

a drug must be eliminated after it has an effect

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24
Q

What are some examples of drug classifications?

A

natural preparations, pure compounds, semi-synthetic compound, synthetic compounds, and biological drugs

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25
Q

What are some examples of therapeutic effect classifications?

A

anti-hypertensives, anti-convulsants, anti-bacterial, anti-fungal, anti-psychotic, anti-arrhythmic

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26
Q

What are drug classification examples in society?

A

prescription, OTC, dietary, herbal, recreational, commercial, agricultural

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27
Q

What three names do drugs have?

A

chemical, generic, and brand

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28
Q

T/F a drug has more than one generic name

A

false

29
Q

How long do patents on a new drug last?

A

20 years

30
Q

T/F exclusive right to see a drug lasts as long as the drug patent

A

false

31
Q

How long does trade name last?

A

50 years

32
Q

How long does it take from patenting to marketing?

A

8-10 years

33
Q

What are the 5 steps in drug development?

A

discovery, study of biological interactions, study of safety, marketing, post-marketing

34
Q

What does the study of biological interactions lead to?

A

increased efficacy, potency, and selectivity

35
Q

What is phase 4?

A

post-marketing studies, ongoing

36
Q

T/F the majority of marketed drugs return their R and D investments

A

false only 2/10

37
Q

What is the global market for pharmaceuticals?

A

over $950 billion

38
Q

What percent of health care expenses in the US is prescription drugs?

A

10-12%

39
Q

What are four ways new drugs are developed?

A

identification of a new drug target, design of a new molecule based on understanding of receptor structure, screening for biological activity of natural products, and chemical modification of a known active molecule

40
Q

T/F the type and number of of initial screening tests depends on the pharmacologic and therapeutic goal

A

true

41
Q

What body systems are studied first for drug effects?

A

cardiovascular and renal

42
Q

Which four results of drug screenings result in modifications to the drug compound?

A

poor bioavailability, interactions with liver enzymes, potential for abuse, potential for drug interactions

43
Q

What is a lead compound?

A

the result of all screening procedures

44
Q

What can receive a “use patent”?

A

a previously known chemical entity discovered to have a new therapeutic use

45
Q

What are the two goal outcomes of toxicity testing?

A

defining the limiting toxicities and the therapeutic index

46
Q

What is acute toxicity?

A

determines the no-effect dose and the maximum tolerated dose

47
Q

What is subacute toxicity?

A

determines biochemical and physiologic effect of long-term dose (weeks to months)

48
Q

What is chronic toxicity?

A

used when drug is expected to be needed in humans for prolonged periods of time

49
Q

What are additional toxicity considerations?

A

effect on reproductive performance, carcinogenic potential, mutagenic potential

50
Q

What are limitations of preclinical testing?

A

time consuming and expensive, need large numbers of animals, animals vs humans needs to be considered, rare adverse effects are not likely to be identified

51
Q

Who oversees human testing?

A

FDA

52
Q

T/F a drug can be completely absent of risk

A

false

53
Q

What are confounding factors in clinical trials>

A

variable nature of most diseases, presence of other diseases or risk factors, subject and observer bias (placebo effect)

54
Q

What needs to be filed with the FDA for drug clinical trials?

A

notice of claimed investigational exemption for a new drug

55
Q

What info does the FDA need to know about a drug?

A

composition and source, chemical and manufacturing info, data from animal studies, proposed plans for clinical trials, names and credentials of physicians conducting trials, key data relevant to study of the drug in humans

56
Q

What does phase 1 entail?

A

effects of the drug as a function of dosage on a small number of healthy volunteers, determine the probable limits of the safe clinical dosing range (sometimes study absorption, half-life, and metabolism)

57
Q

What is the exception for using healthy volunteers in phase 1 of clinical trials?

A

can use individuals with the disease IF the drug is expected to have significant toxicity ex: AIDS, cancer

58
Q

What does phase 2 entail?

A

drug is studied in small number of patients with the target disease to determine efficacy and determine doses

59
Q

What phase do most drugs fail?

A

phase 2, only 25% of new drugs get past phase 2

60
Q

What does phase 3 entail?

A

drug is evaluated in larger numbers (thousands) of patients with the target disease in a clinical setting

61
Q

What needs to be accomplished in phase 3?

A

establish and confirm safety and efficacy, minimize errors caused by placebo effects and disease variations

62
Q

What does marketing approval require?

A

submission of a new drug application NDA with full reports of all preclinical and clinical trials, can take months to gain approval

63
Q

What does phase 4 entail?

A

monitoring the safety of the new drug under actual conditions of use in large numbers of patients, no fixed durations

64
Q

What is the responsibility of a physician using a medication in phase 4?

A

need to report adverse effects

65
Q

What is the average effective patent life for major pharmaceuticals?

A

11 years

66
Q

What happens when a patent expires?

A

any company can produce the drug without paying license fees after filing an abbreviated NDA

67
Q

What percent of prescriptions in the US are for generics?

A

67%

68
Q

What are examples of conflicts of interest in drug development?

A

manufacturers paid physicians to prescribe, sponsoring of poorly designed clinical studies, sponsoring CE events for physicians, distributing samples

Systemic Pharm I (13 decks)

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