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SP1 Pharmacology > Lecture 1 1/23/24 > Flashcards

Lecture 1 1/23/24 Flashcards

1
Q

What constitutes a drug product?

A

the active and inactive components

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2
Q

What is a drug?

A

any substance that brings about a change in biologic function through its chemical action

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3
Q

What is a receptor?

A

a specific molecule that a drug molecule interacts with

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4
Q

What are the potential ways to identify a specific drug?

A

-chemical name
-chemical abstracts registry number
-generic name
-trade name

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5
Q

Which agencies are involved in the regulation of animal drugs?

A

-FDA
-USDA
-EPA
-state pharmacy boards
-state veterinary boards

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6
Q

Which products are regulated by the FDA?

A

-human and veterinary drugs
-biological products
-medical devices
-food supply
-cosmetics
-radiation-emitting products

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7
Q

What is the role of the USDA and APHIS?

A

-regulate veterinary biologics
-regulate drug residues in edible animal tissues

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8
Q

Which products are regulated by the EPA?

A

-topically applied parasiticides
-animal facility insecticides/parasiticides

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9
Q

What are the steps of drug approval?

A

-begins with a sponsor that collects and submits all info about a drug
-NADA process to ensure drug safety, efficacy, and potential adverse environmental effects
-presentation of NADA to FDA; drug can be sold if approved

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10
Q

What are the 5 major sections of the NADA?

A

-target animal safety
-effectiveness
-human food safety
-chemistry, manufacturing, and controls
-environmental impact

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11
Q

What are the 2 minor sections of the NADA?

A

-all other information
-labelling

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12
Q

Who determines if a drug is safe for over-the-counter use or must be used under veterinary oversight?

A

FDA

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13
Q

What are the characteristics of an ANADA?

A

-abbreviated NADA application for generic drugs
-drugs must be proven to be the same as approved brand name
-bioequivalence must be proven
-generic labelling must match approved brand labelling

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14
Q

What is pharmacokinetics?

A

-study of the time course of drug absorption, distribution, metabolism, and excretion
-what the body does to the drug

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15
Q

What is kinetic homogeneity?

A

a predictable relationship between plasma drug concentration and concentration at the receptor site

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16
Q

What is pharmacodynamics?

A

-study of biochemical and physiological effects of drugs, their modes of action, and the relationship between drug concentration and effect
-how a drug behaves in the body

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17
Q

What is drug action?

A

initial consequence of drug-receptor combination

18
Q

What is drug effect?

A

biochemical and physiological changes that occur as a consequence of drug action

19
Q

What is the therapeutic window?

A

range of a drug’s serum concentration at which a desired effect occurs

20
Q

How is the therapeutic index calculated?

A

dividing 50% value of toxicity by 50% value of efficacy

21
Q

How does therapeutic index relate to drug safety?

A

the wider the therapeutic index, the safer the drug

22
Q

What values are most important to determine when conducting therapeutic drug monitoring?

A

-peak: maximum drug efficacy
-trough/low: when to give next dose as to not cause toxicity

23
Q

What is therapeutic drug monitoring?

A

-use of assay procedures to determine drug concentrations in plasma
-interpretation of assays to develop safe and effective drug regimens

24
Q

What are the criteria for conducting therapeutic drug monitoring?

A

-narrow therapeutic window
-variable pharmacokinetics
-correlation between concentration and efficacy
-no alternative therapies

25
Q

What is potency?

A

a measure of drug activity, expressed in terms of the amount required to produce an effect of given intensity

26
Q

How do higher potency drugs differ from lower potency drugs?

A

-higher potency drugs will evoke a given response at low concentrations
-lower potency drugs can only evoke the same response at higher concentrations

27
Q

What is drug efficacy?

A

-the maximum effect that can be achieved by a drug
-how well a drug produces a desired effect

28
Q

What is important about the relationship between potency and efficacy?

A

high potency does not imply high efficacy

29
Q

What is EC50?

A

concentration required to achieve 50% maximal effect of a drug

30
Q

When comparing two drugs, how is it possible to determine the more potent drug?

A

the drug with the lower EC50 has greater potency

31
Q

Which should be favored clinically, efficacy or potency?

A

efficacy

32
Q

What are agonists?

A

drugs that occupy receptors and activate them

33
Q

What are antagonists?

A

drugs that occupy receptors but do not activate them

34
Q

What is a partial agonist?

A

drug that acts at a receptor but produces less than maximal effect

35
Q

What is competitive inhibition?

A

inhibition of a pathway due to one substance competing with another substance

36
Q

Is the effect of a competitive antagonist able to be overcome? If so, how?

A

-yes
-increasing the dose of the agonist can negate the effect of the antagonist

37
Q

What are the two potential types of noncompetitive inhibition?

A

-irreversible binding of antagonist at the receptor
-interaction of the antagonist at a site away from the receptor that prevents initiation of effect

38
Q

Is the effect of a noncompetitive antagonist able to be overcome? If so, how?

A

not completely

39
Q

What are the characteristics of pharmacodynamic tolerance?

A

-response to a given drug concentration is progressively reduced
-concentration needs to keep increasing to maintain the effect

40
Q

What are the potential mechanisms of pharmacodynamic tolerance?

A

-decreased receptor affinity/response
-changes in signaling pathways
-decreases in receptor density
-engaging compensatory mechanisms

SP1 Pharmacology (27 decks)

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