Drug Discovery and Clinical Development Flashcards
Banerjee
1
Q
Once maximal tolerable dose is found, Phase _____ will then explore efficacy and generate Hypotheses
A
II
2
Q
Phase IV clinical trials
A
Determine if drug is safe over time
3
Q
Two requirements for phase 0
A
- Wide Therapueitc Inde
- Known target with Biomarker
4
Q
Phase ____ Studies focus on ADME and Tolerability
A
One
5
Q
in a trial of usually n<20, phase ______ examines suitable pharmacokinetics.
A
0
6
Q
Clinical Phase ______ has about 100-500 volunteers
A
Two
7
Q
Clinical Phase _____ has about 1,000 to 5,000 volunteers
A
Three
8
Q
Clinical Phase ____ has about 20-100 volunteers
A
One
9
Q
The average time it takes to put out a new drug in the US is ______
A
15 years
