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Human disease and therapeutics 2020 > Drug Development FINAL > Flashcards

Drug Development FINAL Flashcards

1
Q

What was the reason for the Pure food and drug act?

A

-Deal with addiction caused by opioids and cocaine.

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2
Q

What does the pure food and drug act require?

A

-Labeling ingredients for patent medicines (“secret ingredients”)

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3
Q

What was the reason for the Modified food drug and cosmetic act?

A

-antibiotics (sulfa drugs) were not soluble so they put in diethylenegylocol that killed a lot of individuals

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4
Q

What did the modified food drug and cosmetic act require?

A

-The drug must be safe (didn’t say that it had to be effective)

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5
Q

What was the Durham-Humphrey Amendment?

A
  • Makes the distinction of Rx vs OTC
  • Looked at the addiction potential
  • Looked at the toxicity
  • What is the indication (self limiting vs non self limiting)
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6
Q

What is the reason for the Kefauver-Harris Amendment?

A

-Thalidomide would cause phocomelia

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7
Q

What did the Kefauver-Harris amendment require?

A

-Safety and efficacy

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8
Q

What does the FDA regulate?

A
  • Food
  • Dietary supplements
  • Bottled water
  • Food additives
  • Drugs
  • Biologics
  • Medical devices
  • Cosmetics
  • Veterinary products
  • Tobacco products
  • Advertising of products
  • Oversee the testing of the drugs
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9
Q

What does the Dietary supplement health and education act regulate?

A
  • Herbal products

- Defines herbal products as foods

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10
Q

How much money does it cost to develop a drug?

A

-1-2 billion

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11
Q

Animal preclinical testing is controlled by what?

A

-Institutional animal care and use committee (IACUC)

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12
Q

What are the 2 species of animals that are tested?

A
  • Rodent

- Depends on what you are looking at testing (pigs and hearts)

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13
Q

What is an IND?

A
  • Investigation new drug

- notice that a new drug will be submitted for FDA consideration

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14
Q

What is phase I?

A
  • Small group of healthy (usually) subjects to test safety, doses, administration and other kinetics
  • Initial clinical phase
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15
Q

What is phase II?

A
  • Small group of subjects with condition to be treated to test safety (still) and efficacy
  • clinical pharmacological phase
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16
Q

What is phase III?

A
  • Extended clinical phase
  • Large group of subjects, using double blind construct, placebos and multi-sites groups to test for statistical efficacy
17
Q

What is phase IV?

A

-Marketing and see how the product does in production

18
Q

What has to happen before a drug can go in to clinical trials?

A
  • FDA approval

- IRB approval

19
Q

What is IRB?

A
  • Institutional review board

- review of proposal for human testing

20
Q

What is the fast track drug?

A
  • Streamline process for urgent situation
  • Qualify for special consideration in FDA-directed process that speeds up the evaluation step and extends the patent for life
21
Q

What is the Orphan drug act?

A
  • For rare disease to encourage drug development (less than 200,000)
  • Gives you increased patent life
  • Tax incentives
22
Q

What is proprietary?

A

-Name brand

23
Q

What is generic?

A

-After patent expires

24
Q

What does DAW mean on a prescription?

A

-Dispense As Written

25
Q

What is non-prescription drug category one?

A
  • Safe and effective for indication

- Most OTCs

26
Q

What is non-prescription drug category two?

A
  • Unsafe or ineffective
  • improper indication
  • Not OTC
27
Q

What is non-prescription drug category III?

A
  • Not sure

- Requires more studies

28
Q

New drugs are always made prescription for at least how many years before considering their conversion to OTC status?

A

-3 years

29
Q

What is the switching policy?

A

-Goes from Rx to OTC

30
Q

Before you can switch from Rx to OTC status what has to happen?

A
  • be a prescription for at least 3 years
  • Good safety record
  • Widely available
  • used frequently to demonstrate a need
  • based on the need to reduce cost
31
Q

What is an NDA?

A
  • New drug application

- the final FDA step of approval/rejection after evaluating all the studies and data from testing phases

32
Q

what is FTC?

A
  • federal trade commission
  • control labelling
  • products in this category cannot be promoted to diagnose, treat, or prevent disease
33
Q

T or F:

the FDA monitors and performs tests on products

A
  • false

- they oversee testing, but do not perform the tests

34
Q

what 3 things determine the distinction between prescription and OTC drugs?

A
  • addiction/abuse liability
  • relative safety
  • intent of use - does it require professional input/control?

Human disease and therapeutics 2020 (60 decks)

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