[1] Drug Discovery and Development

Question 1

What was Menoxidil initially sold for? What is it being used for now?

Answer 1

Originally for colds (Vasodilator)

Showed decreased in BP and Hirsutism as a side effect

Question 2

Define: Pre-Discovery Phase

Answer 2

Phase aimed to understand the disease and underlying cause

Question 3

Define: Phase I Trials

Answer 3

Is the treatment safe?

Initial testing of drug to small number of healthy volunteers

Question 4

Define: Phase II Trials

Answer 4

Does the treatment work?

Evaluate the drug effectiveness in a small number of patients with the disease

Question 5

Define: Phase IIA Trials

Answer 5

Pilot clinical trials to evaluate efficacy and safety in selected populations of patients

Question 6

Define: Phase IIB Trials

Answer 6

Well controlled clinical trials to evaluate efficacy and safety in selected populations of patients

Question 7

Other name for Phase II B Trials

Answer 7

Pivotal Trials

Question 8

Define: Phase III Trials

Answer 8

Will the treatment prolong life?

Tests in a large group of patients (RCT)