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Pharmacology > Pharmacogenetics > Flashcards

Pharmacogenetics Flashcards

1
Q

What are the general steps of drug development

A
  1. Discovery
  2. Effective dosings
  3. Animal testing
  4. Clinical trials
  5. Gather additional info
  6. New drug application with FDA
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2
Q

Why are drug tests done on animals?

A

They give us a prediction of how a drug will work in humans

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3
Q

What are we looking for in animal testing

A

Subacute Toxicity

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4
Q

When do you see chronic toxicitiy

A

When you’ve been on the drug for a long time

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5
Q

There are thousands of drugs discovered each year. Of those thousands how many make it to clinical trials?
How many make it to application?

A

Trials: 5
Application: 1

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6
Q

What are some important limitations in pre-clinical testing

A
  1. It is time consuming and expensive
  2. You have to test a large number of animals
  3. It is not completely reliable (animals aren’t people)
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7
Q

What do you file around the time of animal testing?

A

Patent

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8
Q

How long do patents last for?

What happens after that?

A

10-14 years

After that generics can come out

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9
Q

What does phase 1 look at?

A

Is the drug safe

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10
Q

What does phase 2 look at

A

Does it work, efficacy

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11
Q

What is phase 3 looking at?

A

Does it work and is it safe? Use double blind testing. You will see the common side effects here

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12
Q

What patients do you use in phase1 ? How many do you use?

A

You are using healthy people, EXCEPT for sometimes in cancer and HIV drugs)

Low number of people (20-100)

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13
Q

What patients are used in phase 2?

How many pts are used?

A

People who have the disease

100-200 people

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14
Q

How many people are tested in phase 3?

A

Thousands

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15
Q

Less than _____ of the drugs tested in clinical trials reach the marketplace

A

1/3

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16
Q

What are the. Confounding factors in clinical trials

A
  1. Variable drug history
  2. Presence of other diseases and risk factors
  3. Subject observer bias
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17
Q

You MUST use a large enough population of subjects

A

Yes

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18
Q

What can influence patients

A

The placebo effect

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19
Q

How do you overcome subject and observer bias

A

Double blind design

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20
Q

30-50% is the results of a drug are due to this this

A

Placebo effect

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21
Q

What kind of design is used for clinical trials

A

Crossover

See slide 23 fro an example

22
Q

What does the FDA do?

A

Oversees the drug evaluation process

Makes sure drug is safe and effective

23
Q

Pure food and drug act of 1906

A

In response to unsanitary and unethical practices in meat pacing industry

24
Q

Federal food, drug, ad cosmetic act of 1938

A

Due to series of deaths associated with sulfanilamide

25
Q

What what’s the thalidomide tragedy of 1957?

A

Drug that when taken in pregnancy causes severe birth defects (no arms)

26
Q

How do you evaluate a clinical drug study

A 
You look at the objectives
The experiment methods
The ethics
The stats
Does the drug fifer significant advantages of cost, efficacy, or safety over existing agents?
27
Q

What are orphan drugs

A

Drugs for rare diseases

28
Q

What is considered a rare disease in the US

A

Disease that affect fewer than 200,000 people in the US

29
Q

What is pharmacogenetics?

A

The study of the genetic basis of variation in drug response. Looks at the effects a single gene has on a drug

30
Q

What is pharmacogenomics

A

The study of the whole genomes effect on a drug

31
Q

What is the most common basis for genetic variation

A

Single nucleotide polymorphism (SNP)

32
Q

What is a SNP

A

A single nucleotide is exchanged for another

33
Q

The human genome consists of how many nucleotides

A

3 billion

34
Q

How do SNPs affect the genome

A

They can influence protein expression by altering amino acid sequence

35
Q

What is the central dogma

A

DNA>RNA>Protein

36
Q

How many amino acids are there?

How are they grouped?

A

20

Grouped based on similarities in structures

37
Q

What is a missense SNP

A

Changes the identity of an amino acid

38
Q

What is a conservative missense SNP

A

A.A replaced with another A.A with similar properties

39
Q

Wha is a non-conservative missense SNP

A

A.A is changed to an A.A that is not similar

40
Q

What is a nonsense SNP

A

Leads to a stop codon

41
Q

What is a synonymous (silent) SNP

A

Does not change the amino acid

42
Q

Poor metabolizers and standard drugs

A

Reduced elimination
Increased toxicity
Drug will buildup in body

43
Q

Intermediate metabolizers and standard drugs

A

Possibility increased toxicity risk

44
Q

Rapid metabolizer and standard drugs

A

Reduced effectiveness

Increased elimination

45
Q

Poor metabolizer and prodrug

A

Decreased effectiveness and decreased activation

46
Q

Intermediate metabolizer and prodrugs

A

Possible reduced effectiveness

47
Q

Rapid metabolizer and prodrugs

A

Increased activation
Increased toxicity risk
Very dangerous

48
Q

CYP2C9 affects this drug________

How does it affect it?

A

Warfarin

Increased bleeding risk for patients with CYP2C92 and CYP2C93

49
Q

CYP2C19 affects what drugs?

What affect does it have?

A

Metabolism of proton pump inhibitors

Advantage is Helicobacter pylori eradication

50
Q

CYP2D6 affects what drugs

What is the affect seen?

A

Codeine
CYP2D6*2

Rapid metabolizers: increased option effect (avoid use), increased CYP function

Poor: little or no CYP2D6 function

51
Q

CYP3A4 metabolizers what drugs?

A

Most drugs

52
Q

What is personalized medicine?

A

Use of an individuals genetic information to guide decisions of prevention, diagnosis, and treatment of a disease

Pharmacology (4 decks)

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