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systemic pharmacology i > Intro to Pharmacology > Flashcards

Intro to Pharmacology Flashcards

1
Q

pharmacology

A

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

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2
Q

drug

A

any substance that alters body function when introduced into a living organism;
has some effect on a specific target molecule (receptor)

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3
Q

factors that influence the effect of a drug

A

size, electrical charge, shape, and atomic composition of the drug molecule

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4
Q

pharmacodynamics

A

the actions of a drug on the body;

effects at the receptor and the results

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5
Q

pharmacokinetics

A

the actions of the body on a drug;
absorption, distribution, metabolism, and excretion;
how the drug moves into and out of the body

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6
Q

agonist

A

binds to and activates a receptor;

full agonist or partial agonist

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7
Q

antagonist

A

prevents other molecules from binding to a receptor; prevents receptor from being activated; either reversible or irreversible

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8
Q

the intended site of drug action must be ___ by the drug (administration/absorption)

A

reachable

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9
Q

a drug may reach its intended target as an ____ or it might require conversion prior to it being ____ (metabolism)

A

active molecule;

active (prodrug)

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10
Q

most often a drug is administered into one body compartment and must ____ (distribution)

A

move to the intended site of action

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11
Q

a drug must be ___ after it has an effect (metabolism, elimination)

A

eliminated

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12
Q

drugs have 3 names

A
  • chemical name
  • generic name
  • brand name (proprietary, trade)
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13
Q

chemical name

A
  • complex

- little concern to medical professionals

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14
Q

generic name

A
  • internationally recognized
  • drugs only have one generic name
  • often indicates class or mechanism of action
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15
Q

brand name (proprietary, trade)

A
  • patented exclusive property of manufacturer
  • often shorter and easier to remember
  • one drug may have many trade names
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16
Q

patent on a new drug lasts ___

A

20 years

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17
Q

exclusive right to sell a drug can be much shorter than patent length:

  • certain conditions must be met
  • exists to ___
A

encourage competition

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18
Q

trade name lasts for at least ___

A

50 years

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19
Q

time from patenting to marketing takes ___

A

8-10 years

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20
Q

steps of drug development:

  • _____
  • study of ____
    • leads to increased _____
  • study of ____
    • first in animals then in humans
  • ____
  • ____ studies
A 
discovery;
biological interactions;
efficacy, potency, and selectivity;
safety;
marketing;
post-marketing
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21
Q

most drugs originate in ___ but are developed in ___

A 
research institutions (university, etc.);
pharmaceutical companies
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22
Q

only ____ marketed drugs return their R&D investments

A

2 in 10

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23
Q

global market for pharmaceuticals in 2015 was over ___

A

$950 billion

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24
Q

____% of health care expense in the US is on prescription drugs

A

10-12

25
Q

most new drugs are developed through these approaches:

  • identification of a new ____
  • design of a new molecule based on understanding of ____
  • screening for ____ of natural products
  • chemical modification of a ____
A

drug target;
receptor structure;
biological activity;
known active molecule

26
Q

once identified, the process moves to ____

A

translational research (preclinical and clinical testing)

27
Q

the type and number of initial screening tests depends on the _____

A

pharmacologic and therapeutic goal; anti-infectives tested against many different infectious organisms, etc.

28
Q

the molecule is also tested for a broad array of other actions:

  • helps determine the ____
  • determines ___
A

MOA;

selectivity

29
Q

pharmacologic profile is studied: defines the _____ of the molecule

A

pharmacokinetics and pharmacodynamics

30
Q

animal studies help determine the ____ and disease models; ____ studies are usually first

A

effect on organ systems;

cardiovascular and renal

31
Q

modifications to the compound may result from screening:

  • poor ____
  • interactions with ____
  • potential for ____
  • potential ____
A

bioavailability;
liver enzymes;
abuse;
drug interactions

32
Q

the result of all screening procedures is a ___

A

“lead compound”

33
Q

lead compound:

  • leading ____ for a successful new drug
  • if it is a new compound a ___ will be filed
  • a previously known chemical entity discovered to have a new therapeutic use can receive a ___
A

candidate;
patent application;
“use patent”

34
Q

toxicity testing

A

seek to define the limiting toxicities and the therapeutic index; how toxic is this compound?

35
Q

usually go through the following toxicity tests

A
  • acute toxicity
  • subacute toxicity
  • chronic toxicity
  • effect on reproductive performance
  • carcinogenic potential
  • mutagenic potential
36
Q

acute toxicity test

A

determines the no-effect dose and the maximum tolerated dose

37
Q

subacute toxicity test

A

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

38
Q

chronic toxicity test

A

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

39
Q

preclinical testing goal

A

to determine potential human toxicities and to design tests to further define the toxic mechanism; also predicts the most relevant toxicities to monitor in clinical trials

40
Q

limitations of preclinical testing

A
  • time-consuming and expensive (can take up to 6 years)
  • large numbers of animals needed to obtain valid data (computer modeling and cell cultures are increasingly being used)
  • animal to human toxicity data not always predictive
  • rare adverse effects are not likely to be identified
41
Q

human testing:

  • very ___ guidelines
  • overseen by the ___
  • “safe” can mean different things to patient, physician, and society- no drug can be completely absent of ___
A

strict;
FDA;
risk

42
Q

confounding factors in clinical trials

A
  • variable nature of most diseases
  • presence of other diseases or risk factors
  • subject and observer bias - placebo effect
43
Q

Notice of Claimed Investigational Exemption for a New Drug (IND):

  • filed w/ FDA
  • includes:
A
  • composition and source of the drug
  • chemical and manufacturing information
  • all data from animal studies
  • proposed plans for clinical trials
  • names and credentials of all physicians who will conduct the trials
  • compilation of the key data relevant to study of the drug in humans
44
Q

clinical trials: Phase 1

A
  • effects of the drug as a function of dosage
  • small number (20-100) of healthy volunteers
  • determine the probable limits of the safe clinical dosing range
  • can use individuals with the disease IF the drug is expected to have significant toxicity (ex: cancer or AIDS therapy)
  • absorption, half-life, and metabolism are also often studied in this phase

*small number of healthy volunteers; what is the effective dose?

45
Q

clinical trials: Phase 2

A
  • the drug is studied in patients with the target disease to determine efficacy
  • also helps determine doses to be used in follow-up trials
  • 100-200 subjects used
  • have the highest rate of drug failures
  • only 25% of new drugs get past phase 2

*small number of patients with the target disease; does this drug work?; highest rate of drug failures

46
Q

clinical trials: Phase 3

A
  • drug is evaluated in larger numbers of patients with the target disease (usually thousands of patients)
  • establish and confirm safety and efficacy
  • designed to minimize errors caused by placebo effects and disease variations
  • usually performed in settings similar to what is anticipated for the ultimate use of the drug (hospitals, clinics, etc.)
  • if results meet expectations, application is made for permission to market the new drug

*large number of patients with the target disease; is this drug safe and does it work?

47
Q

clinical trials: marketing approval

A
  • requires submission of a New Drug Application (NDA)
  • full reports of all preclinical and clinical data
  • can take months to years to gain approval
  • if urgent need for the drug is perceived, the process of FDA review can be accelerated
  • once approval has been granted, phase 4 studies begin
48
Q

clinical trials: Phase 4

A
  • monitor the safety of the new drug under actual conditions of use in large numbers of patients
  • requires reporting by all physicians using the medications
  • some adverse effects may become apparent only after chronic dosing
  • no fixed duration (as long as the drug is in use)
49
Q

lifetime of a patent is ____; often includes the ____; average effective patent life for major pharmaceuticals is around ___

A

20 years;
approval time (5 years or more);
11 years

50
Q

when the patent expires any company can produce the drug without paying license fees to the original patent owner

A
  • file an abbreviated new drug application (ANDA)
  • demonstrate required equivalence
  • market the drug as a generic product
  • occasionally paid by patent owner NOT to introduce a generic version
51
Q

___% of prescriptions in the US are for generics

A

67

52
Q

conflicts of interest:

-manufacturers often “paid” physicians to ___

A

use their medications in preference to older drugs

53
Q

conflicts of interest:

-sponsored small and poorly designed clinical studies after marketing approval

A

publish favorable results but often hold back unfavorable resutls

54
Q

conflicts of interest:

-sponsored CE events for physicians and staff

A

attractive vacation sites

55
Q

conflicts of interest:

-distribute ___

A

samples of new drugs

56
Q

pharmacogenomics

A

genetic makeup and the individual response to specific drugs

57
Q

full agonist

A

light is either on or off

58
Q

partial agonist

A

light has a dimmer- on but not all the way

59
Q

biological drugs

A

drugs created by antibodies; MAB= monoclonal antibodies

systemic pharmacology i (7 decks)

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