Question

8. Which is the best predictor of need for drug dosage adjustment in hepatic disease?

1. Child Pugh score
2. Portal splanchnic pressure (as measured by peripheral heart rate)
3. Degree of fibrosis and shunt on ultrasound
4. Levels of liver function tests
5. In vivo drug interaction trials

9. Fexofenadine is not metabolized but is a P-glycoprotein (Pgp) substrate. How does St. John’s Wort cause decreased serum fexofenadine levels?

1. Inhibition of gut Pgp
2. Induction of gut PgP
3. Induction of CNS Pgp
4. Inhibition of biliary Pgp
5. None of the above

10. Which of the following is the best measure of renal function?

1. age
2. random urine creatinine concentration
3. spot plasma creatinine concentration
4. estimated creatinine clearance (Cockroft Gault)
5. Child-Pugh

44.

Why are concentration-response analyses recommended for drug approval by a regulatory agency?

1. To increase the potential for adverse reactions in clinical trials in order to fully characterize the safety profile
2. Dose response is a better predictor of drug efficacy than exposure response
3. To maximize the likelihood that optimal drug dose will be prescribed after approval
4. To reduce the costs of clinical trials
5. To explore all possible disease state indications at time of initial approval