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BIOL *1080 > Lecture 4 > Flashcards

Lecture 4 Flashcards

1
Q

What are 2 things MUST be done in human clinical trials

A
  1. Must go through rigorous review by international ethics review board
  2. Must always done with volunteers
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2
Q

What are the purposes of human clinical trials

A

Performed to test new drug safety

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3
Q

What are the order of trials

A
  1. Preclinical
  2. Phase I clinical trials
  3. Phase II clinical trials
  4. Phase III clinical trial
  5. After approval
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4
Q

What goes on in preclinical trials

A

Animal studies before testing on humans

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5
Q

What goes on in phase I clinical trials

A
  • Is the drug safe for humans?
  • What is a face dose?
  • What are the side effects?
  • Test done on a small group of people
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6
Q

What goes on in phase II clinical trials

A
  • Does the drug work for its intended purpose (effectiveness)
  • How well does the vaccine work
  • Is it safe on a larger group of people
  • What is the safest and most effective approach
  • Test done of large group of people (100s)
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7
Q

What goes on in phase III clinical trials

A
  • How does the drug compared to other treatments available
  • Does the vaccine prevent diseases
  • What Are the side effects
  • Larger group of people (1000s)
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8
Q

What goes on in after approval

A
  • Manufacturer submits applications to health Canada for reviews
  • Ongoing assessment of long-term use, benefits, and risks
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9
Q

What are the order of reviews and approval of vaccines

A
  1. Scientific Review
  2. Approval
  3. Distribution
  4. Vaccination
  5. Mobitering
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10
Q

What happens during scientific review of vaccines

A

Health Canada experts conduct through and independent review of vaccines

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11
Q

What happens during approval of vaccines

A

Health Canada approves vaccine IF: It is safe, works, meets manufacturing standers, and benefits outweigh risks

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12
Q

What happens during distribution of vaccines

A

Government coordinates the purchase, logistics, and distribution of vaccines across Canada

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13
Q

What happens during vacination of vaccines

A

All Canadians have access to vaccines

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14
Q

What happens during monitoring of vaccines

A

Continuous monitoring takes place to confirm safety of vaccine and that the benefits outweigh the risks

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15
Q

What is evidence-based medicine

A

Applying scientific evidence to clinical decisions

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16
Q

What are Cochrane reviews

A

A database of systematic reviews and meta-analysis which summarize and interpret the results of medical research

17
Q

What is the pyramid of evidence based medicine

A
  1. In Silico research
  2. In vitro research
  3. Animal model research
  4. Case-control surrey studies
  5. Cohort survey studies
  6. Randomized controlled trials
  7. Clinically appraised papers
  8. Clinically appraised topics
  9. Systematic reviews
18
Q

What are the outcomes of evidence based medicine

A

Patient values, clinical data and research evidence are taken into considerations

Optimal decisions are the outcomes

19
Q

What are the 4 new dimensions in medical and healthcare practice

A
  1. Evolutionary medicine
  2. Integrative medicine
  3. Collective medicine - eco health medicine and one health/one world/one medicine
  4. Enhancement medicine
20
Q

What is evolutionary medicine

A

AKA Darwinian medicine

Application of modern evolutionary history to understand health and disease

Replaces previous view of body as machine to biological view of body shaped by evolutionary process

21
Q

What are examples of evolutionary medicine

A

Is the modern diet unhealthy? Should we try to mimic early diets

We get very little exercise in modern society … is this a signal were injured and need to flow down metabolism to initiate inflammatory response

We all have fight or flight responses but if it’s always “on” is there really any follow through

22
Q

What is integrative medicine

A

Treats the whole person, not just the disease symptoms

Healing-oriented medicine that takes account of the whole person, including aspects of their lifestyle

Makes use of all appropriate therapies

23
Q

What is collective medicine

A

One health’s mission: promote, improve and defend the health and wellbeing of all species by enhancing cooperation and coloration between physicians, veterinarians and other scientific health professionals

Concept - speaks to interconnectedness of animal, human, and environmental health

Approach - working together across disciplines with complex health issues that arise in the intersection of human, animal and environmental health

24
Q

Examples of enhancement medicine

A
  1. Botox
  2. Viagra and others
  3. Anabolic steroids
  4. Liposuction
  5. Fertility drugs
  6. Erythropoietin
  7. Laser vision enhancement
25
Q

Examples of nootropics (brain enhancers)

A
  1. Cholinergic stimulants
  2. Dopaminergics
  3. Natural compounds (omega 3- fatty acids)

BIOL *1080 (19 decks)

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