Lecture 19

1.
How are drugs discovered?
Herbal remedies, seredipity (chance), phenotypic, ration drug design
2.
What is the phenotypic approach?
Chemical library screening in cells
3.
What information rises from clinical studies?
PKPD (efficacy, ADME, toxicity)
4.
What are the types of toxicology?
Acute, mutagenic, tetarogen
5.
What does toxicity tell us?
Which organs, safe dose, cancer?
6.
What does PKPD tell us?
Therapeutic index
7.
What does ADME tell us?
CYP, induction/inhibition, metabolites, administration
8.
What are the features of phase 1 trials?
Small number, safety focused, healthy volunteers
9.
What are the features of phase 2 trials?
Several hundred, diseased volunteers, controlled
10.
What are the features of phase 3 trials?
Several thousand patients, dose, ADRs
11.
What are the features of phase 4?
Post marketing surveillance, rare ADRs, common ADRs confirmed
12.
13.
14.
Why was Rofecoxib withdrawn?
Increased risk for cardiac arrest and stroke