Intro to Pharmacology Flashcards

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1
Q

what occurs during pre-clinical phase of drug trials?

A

submit data that drug is reasonably safe for initial small-scale clinical studies via in vitro, animal studies, or foreign marketing experience

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2
Q

what do animal and cell culture toxicity studies show?

A

genotoxicity. toxicity of metabolites, basic elimination data

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3
Q

what occurs during phase I clinical trials?

A

introduction into a small number of HEALTHY human volunteers after establish reasonable safety

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4
Q

what is the goal of phase I clinical trials?

A

determine drug’s pharmacokinetics and pharmacodynamics

and eval drug metabolism, structure activity relationship, MOA

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5
Q

what occurs during phase II clinical trials

A

tested on small populations (100-200) with the disease for which the medication is indicated

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6
Q

what is the goal of phase II clinical trials?

A

preliminary assessment of efficacy

helps determine short term side effects

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7
Q

what occurs during phase III clinical trials

A

controlled and uncontrolled trials, labeling is approved

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8
Q

what is the goal of phase III clinical trials

A

gather more info about efficacy, safety, and benefit/risk relationship

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9
Q

what approves product labeling?

A

the FDA, and an Abbreviated New Drug Application (ANDA) must be filed for approval for change

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10
Q

what occurs during phase IV clinical trials

A

post marketing surveillance where adverse events are reported from a large, diverse population

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11
Q

what is the goal of phase IV clinical trials

A

ID of idiosyncratic and rare side effects

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12
Q

how long are OTC rx valid

A

1 year from write date

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13
Q

how long are legend (non OTC) drug rx valid? (

A

1 year from date written unless drug is controlled by Drug Enforcement Agency due to risk of abuse

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14
Q

regulation for schedule II medications?

A

Rx must be written, cannot be refilled

to get around this, write multiple rx with correct date, and write do not fill before date

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15
Q

regulation for refills for schedule III

A

up to 5 refills in 6 months

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16
Q

regulation for refills for schedule IV

A

up to 5 refills in 6 months

17
Q

regulation for refills for schedule V

A

varies by state, but probably up to 5 refills in 6 months or pharmacist can dispense without Rx

18
Q

side effect vs allergy

A

side effect is a predictable, dose related expression of the drug’s activity, where an allergy is an adaptive immune response to an Ag

19
Q

what is an idiosyncratic reaction

A

reaction that we cannot explain due to extension of mechanism of action, and are not dose related