Neuro-Clincial Trials and Pharmogenetics

Question 1

What is a lead compound

Answer 1

Chemical compound that has pharmacological or chemical activity where the structure is used as a starting point for chemical modifications in order to improve parameters

Question 2

What is the goal of preclinical testing

Answer 2

Determine and predict safety and toxicity without use on humans

Question 3

What is being tested for in phase 0

Answer 3

-Subclinical/microdosing in volunteers to help try predict pharmokinetics

Question 4

What is the being tested for in phase 1

Answer 4

• In a small amount of healthy volunteers
• absorption, half life, and metabolism
• To see if data correlated from mice or humans

Question 5

What is being tested in phase 2

Answer 5

• Larger group of sick patients, in order to see if there is efficacy
• single blind study with placebo
• efficacy, dosing amounts, and toxicities measured
• Most common place to fail

Question 6

What is being tested in phase 3

Answer 6

• Large studies to target the disease, looking at everything
• usually a double blinded study in order to minimize errors
• To evaluate the overall risk-benefit of the drug