Drug Evaluations and Pharmacogenetics

Question 1

Preclinical Safety Testing

Answer 1

on animals
in vitro
not completely reliable data when transferred to human use

Question 2

Phase 1

Answer 2

20-50
tested on healthy people
to see if the drug is safe

Question 3

Phase 2

Answer 3

100-200
tested on sick people
to see if the drug is effective

Question 4

Phase 3

Answer 4

1000-6000
Safety and efficacy
double blind

Question 5

A new drug must file a ______ to begin human trials

Answer 5

Investigational New Drug Application

Question 6

After passing human trials, drugs file a ______ to hit open market

Answer 6

New Drug Application

Question 7

Phase 4

Answer 7

Marketing

Question 8

Orphan Drugs

Answer 8

for diseases affecting less than 200,000

often will not get enough funding/ profit because of so few affected

Question 9

Missense SNP

Answer 9

change in structure or function of protein

Question 10

Nonsense SNP

Answer 10

stop codon

Question 11

Synonymous/ Silent SNP

Answer 11

does not affect structure or function of protein

Question 12

CYP2C9

Answer 12

metabolizes drugs with small TI- warfarin

if has this allele warfarin will not metabolize and will increase risk of bleeding

Question 13

CYP2C19

Answer 13

metabolizes proton pump inhibitors

Question 14

CYP2D6 and Codeine

Answer 14

ultra rapid metabolizer

increased opioid medicated affects if have 2 alleles

Question 15

CYP2D6 Poor Metabolizer

Answer 15

little or no function

Question 16

CYP2D6 Ultra Rapid Metabolizer

Answer 16

greater than normal function

Question 17

CYP2C19 Poor Metabolizer

Answer 17

increased efficacy of proton pump inhibitors

removes Helicobacter pylori faster

Question 18

CYP3A4

Answer 18

metabolizes most drugs