2_Pharma Interactions Flashcards

1
Q

what are the stages of clinical trials?

A

pre clinical, 1, 2, 3, FDA, 4

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2
Q

pre clinical trials are trials using:

A

not people (animals, petri dishes)

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3
Q

there are ______ compounds that are tested for every ____ that is approved by the FDA

A

5,000 to 1 (only 1000 ever make it to humans)

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4
Q

What stages are used on people?

A

1,2,3

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5
Q

it takes approximately ____ years to get a drug to be approved by the FDA

A

15 years

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6
Q

total cost of getting 1 drug produced?

A

1 billion

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7
Q

stage one is when you ____ and you only care about _____

A

when you start giving it to people WHO ARE HEALTHY, you don’t care if it works, only if it’s safe, what should the dose be, and how is it metabolized

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8
Q

phase 2 is:

A

slightly larger than 1, you start wondering if it’s effective and PEOPLE WHO ACTUALLY HAVE THE DISEASE

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9
Q

phase 3:

A

you increase the sample size and start comparing it to the standard therapy, evaluate the risks

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10
Q

it usually takes ___ stage ____ trials to bring the drug to market

A

2 stage 3 trials

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11
Q

phase 4 is ______ , and can test:

A

after it comes to market, “lets see how it works for this subset of the population with this certain disease” etc

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12
Q

stage 1 ______

A

safety, dosage, pharmacokinetics; HEALTHY PEOPLE

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13
Q

Stage 2:

A

effectiveness and possible short term side effects, PEOPLE WITH DISEASE, 200-300, double blind study to test safety and efficacy of drug x bs placebo in patients with hypertension

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14
Q

Stage 3:g

A

decided dose that will be given to FDA, how effective, side effects, longer study, 100s to 1000s and tested against the effectivelness of Another FSDA approved drug

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15
Q

Example of 2:

A

200 people in 2x (double) blind study to teest efficay of drug x vs placebo

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16
Q

example for 3

A

300,000 people double blind to test efficacy of drug x vs leading fda approved drug