Drug Development Flashcards

1
Q

What is drug discovery?

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2
Q

What are the beginning steps of drug development?

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3
Q

How are most drugs developed or discovered?

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4
Q

What is drug screening?

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5
Q

What’s the objective to preclinical safety and toxicity testing?

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6
Q

What are the various goals of preclinical and toxicity testing?

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7
Q

What are the safety tests that are carried out during preclinical testing ?

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8
Q

What are the limitations of preclinical testing?

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9
Q

How rigorous are clinical trials?

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10
Q

What must notice of claimed investigational exemption for a New drug (IND)?

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11
Q

In each phase of clinical trials, patents or volunteers…

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12
Q

Give a description of clinical trials

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13
Q

What are subject & observer bias?

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14
Q

Describe the double observer bias

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15
Q

What are Prephase 1 clinical trials?

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16
Q

What are phase 1 clinical trials?

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17
Q

Describe phase 2 clinical trials

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18
Q

What do phase 3 clinical trials?

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19
Q

When does new drug application occur (NDA)?

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20
Q

Describe phase 4 studies

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21
Q

Describe the life cycle of drug approval

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22
Q

What are the requirements of drug labeling?

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23
Q

Describe off label use

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24
Q

Describe the black box warning

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25
Q

What are orphan drugs?

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26
Q

What is fast track status?

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27
Q

What is pharmacoepidekiology?

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28
Q

What are the controlled substances FFA keeps in minds for potential of abuse?

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29
Q

What are the restrictions regarding prescription writing?

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