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IDIT Exam 1 > Intro to Pharmacology > Flashcards

Intro to Pharmacology Flashcards

1
Q

What is pharmacokinetics?

A

What the body does to the drug.

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2
Q

What is pharmacodynamics?

A

What the drug does to the body.

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3
Q

What phase of drug testing is the most costly?

A

Phase III

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4
Q

How many patients participate in phase III of drug testing?

A

Hundreds to thousands in a large, multi-state sample

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5
Q

How long does it take to complete phase III?

A

3-5 years

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6
Q

What is established in phase III?

A

Safety and efficacy

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7
Q

What is assessed in phase III?

A

Drug-drug interactions

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8
Q

What information is generated in phase III?

A

Risk-benefit information

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9
Q

What happens if phase III is successful?

A

An NDA is filed with the FDA which can take 1-2 years to review.

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10
Q

What happens if the drug is approved?

A

It can be marketed.

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11
Q

How long does it take to develop a drug?

A

12 years

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12
Q

What range of money has a single drug taken to be developed.

A

$186 million to $2.6 billion

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13
Q

What happens in phase IV of drug testing?

A

Additional uses of drugs are discovered and post-marketing surveillance.

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14
Q

What are black box warnings?

A

The warn as to the possibility of a higher frequency of adverse effects in subpopulations (gender, age or ethnic groups)

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15
Q

What does the FDA use-in-pregnancy rating of A mean?

A

Controlled studies in humans show no risk to fetus

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16
Q

What does the FDA use-in-pregnancy rating of B mean?

A

No evidence of risk in humans. No studies on humans; animal studies show not risk to fetus

17
Q

What does the FDA use-in-pregnancy rating of C mean?

A

Risk cannot be ruled out. No studies on humans and any animal studies may show risk. Benefits may outweigh risks.

18
Q

What does the FDA use-in-pregnancy rating of D mean?

A

Evidence of risk to fetus in humans exists; benefits may outweigh risks in certain situations (life-threatening)

19
Q

What does the FDA use-in-pregnancy rating of X mean?

A

Risk outweighs any possible benefit as studies in humans and animals demonstrate fetal abnormality

IDIT Exam 1 (10 decks)

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