Between Dose and Response: Pharmacokinetics, Pharmacodynamics, and Statistics
1. Introduction – Why is a statistician giving this lecture?
2. What is pharmacokinetics (PK)?
3. What is pharmacodynamics (PD)?
4. “Population PK/PD ” and statistics
5. Concluding remarks
What do we want in a drug?
• Safety
• Efficacy and effectiveness
Can people take it without bad stuff happening, and does it work?
The usual paradigm: Look at “what goes in ” and “what comes out”
• For a response that we hope the drug affects (e.g., clotting index,headache severity, survival time,etc.) if we were to administer the drug at some dose to the population of patients, what would the average response be?
• . . . And how does it compare to the average response for competing drugs or for other doses of this drug?
• . . . And do any bad side effects (toxicities) occur?