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Drugs 183 > Class #11 - Drug Development > Flashcards

Class #11 - Drug Development Flashcards

1
Q

King Charles (1500) experiment?

A

Thief given bezoar stone (found in goat stomach) with poison to see if would protect him, he died. Spanish noble claimed he wouldn’t.

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2
Q

Jacques Cartier and Scurvy?

A

Natives gave him cure by making a tea out of tree containing vit. C.

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3
Q

First clinical trial on Scurvy?

A

James Lund, hypo since its rare on land caused by diet. 6 groups of two + control. Orange and lemon survived. Lime jus mixed with Rum since then.

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4
Q

Dropsy trial?

A

William Withering with fox glove.

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5
Q

Hierarchy of evidence?

A

Meta - RCT (double-blind) - Cohort studies - Case control - Cross sectional - animal/in vitro - Case report/opinion

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6
Q

Observational studies with definitions (3)? general particularity?

A

No control over environment.

  1. Cross-sectional: Obs of one single point in time of data, no cause-effect relationship (RS).
  2. Case-Control: Compare risk factors between individuals in population. Retrospectively compare. Try to determine RS, cannot prove cause-effect.
  3. Cohort: Follow people over time. detect change in heatlh in RS with risk factors.
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7
Q

Drug to market steps?

A
  1. Idea/discovery
  2. In Vitro: Any benefits? /Animal: Determine safety and LD50.
  3. Investigational New Drug Application: Tell Health Canada
  4. Phase 1: Evaluate safety on healthy participants, 10s of subjects.
  5. Phase 2: 100s subject with disease, RCTs
  6. Phase 3: 1000s subject with disease, up to 5 years, RCTs
  7. New drug application
  8. Decision by gov.
  9. Review of data
  10. Approved vs Rejection
  11. Phase 4: Studying people now that drug is on the market.
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8
Q

Arteminisin treat of? Came from?

A

Malaria, Chinese folklore

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9
Q

Eg of plant origin of drugs: Yew tree

A

Taxol anti-cancer

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10
Q

Eg of plant origin of drugs: Autumn crocus

A

Colchicine: gout

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11
Q

Eg of plant origin of drugs: Periwinkle

A

Vincristine - anti-cancer

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12
Q

Eg of plant origin of drugs: Rauvolfia

A

Reserpine: anti HTA

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13
Q

Banting and Best found insulin by studying?

A

Dogs

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14
Q

Most drugs don’t make it past?

A

Animal studies

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15
Q

Eg drug pull out of market?

A

Thalidomide; Hismanal (anti-His.) - giving arrythmias; Baycol (statin) - musc. weakness and kidney injury; Redux - heart abnormalities; Vioxx (anti-arthritis) - Augmented risk heart disease

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16
Q

Accelerated Approval? Recent example?

A

2-4 months if treat for serious conditions. Gleevec: anti-cancer for myeloid leukemia.

17
Q

Jesse Gelsinger and Emily?

A

Anti leukemia drug, caused cytokine storm to first, saved second.

18
Q

U Toronto bias in research study?

A

70 sudies on cardiac meds = 96% of supportive researchers ties to cie; 37% of critical researcher ties to cie.

19
Q

Viagra name?

A

“vigor” + “niagara falls”

20
Q

Cialis name?

A

“ciel” “sky is the limit”

21
Q

Lipitor name?

A

“lipid” + “organic”

22
Q

Xenical name?

A

“X” + “Calories”

23
Q

Eg of name confusion?

A

Celexa (depression), Cerebryx (seizures), Celebrex (arthritis)

24
Q

Pharma marketing budgets?

A

US: 12billions/year
Ca: 1 billion/year
23% of their budget vs 16% in R&D

25
Q

Patent protection?

A

Bill 91, 20 years starting during first trial

26
Q

Generics the same?

A

No b/c different excipients, but shown same bioavailability.

27
Q

Orphan Drug? Eg?

A

Drugs for rare diseases.
Gaucher Disease caused by lack of Glucocerebroside building up in WBC attacking every organ. Due to lack of Imiglucerase, the Enz converting it to Glucose Ceramide which is inoffensive.
Rx: Cerezyme costing 25 000/month

28
Q

Languages of science?

A

latin -> german -> english

29
Q

between 96-2011 how many active researchers? publications?

A

15milions

26 millions

30
Q

Popeye misconception?

A

1870 Erich found 35mg of iron in 100g of spinach, mistake 3.5mg

31
Q

Communal reinforcement?

A

Claims becoming realities/strong belief through repetition

32
Q

Wright brother first flight?

A

1903, 120 yards.

33
Q

Langley plane?

A

1896, stream powered, no people on it.

34
Q

Otto Lilienthal plane?

A

1893 - a person on glider

35
Q

DNA discoveries history?

A

1869 - Frederich Miescher: something different in cells
1944: Oswald Avery: Substance with replication capacity, caught the attention of Watson and Crick
Rosalind Franklin: X-ray cristal work
Watson and Crick DNA structure: 1953

36
Q

Linus Pauling and DNA?

A

1952 article on nucleic acid, but was wrong about structure

37
Q

First journal to do peer review?

A

1843: Journal of Chemical Society (UK)

Drugs 183 (13 decks)

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