week 11

Question 1

personalized medicine

Answer 1

• tailoring of medical treatment to the individual characteristics, needs, and preferences of the patient
• shifts emphasis in medicine from reaction to prevention
• reductions in costs of trials

Question 2

single nucleotide polymorphisms

Answer 2

• most common form of genetic variability
• single base changes in the DNA
• variation in genes coding for drug target proteins may result in differences in drug efficacy and side effect profile

Question 3

pharmacogenomics

Answer 3

• study of drug response based on genetic makeup and variability

Question 4

pharmacodynamics

Answer 4

• what does the drug do to the body
• involves biochemical pathway and psychological effects affect drug efficacy, toxicity and choice of treatment

Question 5

pharmacokinetics

Answer 5

• what does the body do to the drug
• involves ADME, affects dose, delivery, and dosage regimen

Question 6

sources drug response variations arise from

Answer 6

• genetic factors
• environmental factors

Question 7

pharmacological and toxicological consequences of drug metabolism

Answer 7

• inactivation: active drug to inactive product
• activation: inactive prodrug to active product
• maintenance of activity
• increased chemical reactivity - protein, lipid, DNA binding

Question 8

hepatic enzymes

Answer 8

• act on drugs to help eliminate them
• it is part of evolutionary system to eliminate foreign compounds, usually the enzymatic reaction results in a more water-soluble product

Question 9

variability in drug-metabolizing enzymes

Answer 9

• can alter metabolite levels, which can assist physicians

Question 10

diagnostic test

Answer 10

medical test performed to aid in the diagnosis of a disease

Question 11

therapeutic

Answer 11

a treatment, therapy or drug

Question 12

FDA-approved smoking cessation treatments

Answer 12

• varenicline
• nicotine replacement therapy
• bupropion

Question 13

challenges in personalized medicine

Answer 13

• how do we get genomic information into a patients electronic medical record
• if new drug is directed against target that only a subset of cancer patients have, potential market size is lower than a broadly-prescribed drug

Question 14

progress in personalized medicine in drug development

Answer 14

• can be translated to drug development with a personalized medicine approach

Question 15

project GRADIENT

Answer 15

Genomic Research Approach for Diversity and Optimising Therapeutics

Question 16

genetic variability

Answer 16

can affect the pharmacodymanic and pharmacokinetic properties of a drug

Question 17

major depressive disorder

Answer 17

• common
• includes: depressed mood, reduces interest or pleasure in previously enjoyable activities, recurrent thoughts of death
• depression rates increased 30% since pandemic in adults

Question 18

seratonin reuptake inhibitors (SSRIs)

Answer 18

• many traditional antidepressants block seratonin uptake at the synapse
• many non-responders and side effects
• limitations to sertonin theory
• adverse effects increased risk of suicidality in children and young adults aged 18-24

Question 19

esketamine

Answer 19

• rapid acting
• analogue of ketamin
• affects neuroplasticity
• nasal spray
• taken under medical supervision
• for treatment-resistant major depressive disorder
• less suicidal effects than SSRIs
• target: open channel of NMDA receptors, involved in neuron communication

Question 20

gepirone

Answer 20

• agonist at serotonin 1A receptor
• antagonist at seretonin 2A receptor
• extended release
• reduced side effects
• different target profile

Question 21

forced swim test

Answer 21

• uses idea of “giving up” in depression
• mice swim in water for 5 minutes and then “give up” swimming and float instead
• used to treat antidepressant drugs
• not popular anymore

Question 22

what alternative tests may assess

Answer 22

• specific behaviours associated with mental health
• enjoyment of life
• healthy sleep patterns
• resilience in stress

Question 23

stress

Answer 23

• response to an external cause
• goes away once situation is resolved
• can be positive or negative

Question 24

anxiety

Answer 24

• response is internal
• reaction to stress
• involves persistent feelings of apprehension or dread that doesnt go away
• is constant
• 2nd most common mental illness

Question 25

drug use and birth defects

Answer 25

• only 2-3% of birth defects are thought to be associated with drug treatment during pregnancy
• alcohol, cocaine, and 11 perscription drugs
• 3 suspected prescription drugs

Question 26

clinical trials and pregnancy

Answer 26

• 1977: women with reproductive potential could not participate in trials
• 1993: ban was lifted
• 1994: clinical trials included pregnant woman IF it was safe
• currently: women can participate in research under FDA common rule subpart B; criteria 10 must be met

Question 27

drug development in pediatric populations

Answer 27

• historically children were protected from research
• more recently idea has changed to protecting children through research
• difficult to recruit patients
• consent
• ethics

Question 28

pediatric exclusivity provision

Answer 28

• FDA initiative to incentivize companies to conduct pharmacokinetic studies or small clinical trials in children
• important when a drug may be useful for children or could pose a serious risk if studies arent completed