Neuro-Clincial Trials and Pharmogenetics Flashcards Preview

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Flashcards in Neuro-Clincial Trials and Pharmogenetics Deck (6)
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1

What is a lead compound

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

2

What is the goal of preclinical testing

Determine and predict safety and toxicity without use on humans

3

What is being tested for in phase 0

-Subclinical/microdosing in volunteers to help try predict pharmokinetics

4

What is the being tested for in phase 1

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

5

What is being tested in phase 2

-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

6

What is being tested in phase 3

-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