Lecture 12 - Drug Development and Clinical Trials

Question 1

Phases of drug development? (0->4)

Answer 1

Prediction for humans, tolerability, effectiveness, safety, post marketing

Question 2

Phase 1 - Tolerability?

Answer 2

gradual increase of dose up till adverse effects

Question 3

Phase II - Effectiveness?

Answer 3

learn dose-response curve, effective doses and target concentration

Question 4

Phase III - Safety?

Answer 4

toxicity screening, learning effective dose

Question 5

Phase 4 - Post-marketing?

Answer 5

confirm effective dose, confirm adverse effects (common and uncommon), pharmacoeconomics

Question 6

Trial sequence types?

Answer 6

parallel, crossover, titration

Question 7

Analysis perspective types?

Answer 7

intention to treat (pharmacoeconomic perspective) and as treated (developmental science perspective)