PHA 5127 Case Study 6 Fall 2007 SET I: True or False T F 1: For a multiple IV bolus regimen, if the dosing interval is the same, the shorter the half-life the more pronounced the differences between peak and trough concentrations. T F 2: For a multiple IV bolus regimen, the longer dosing interval, the longer it will take to achieve steady state. T F 3: For a multiple IV bolus regimen, AUC at steady state within one dosing interval increases with the increase in dose. T F 4: For a multiple IV bolus regimen, the accumulation degree is larger in patients with higher clearance. T F 5: It takes more time to reach steady state for a drug with a higher degree of accumulation. (Assuming loading dose is not given, and dosing interval is the same.)SET II: A clinical study for drug X was conducted in 120 healthy volunteers. Drug X was given via IV bolus. The pharmacokinetics of Drug X can be described by linear one-compartment model. Volume of distribution of this drug is 13.3 L, and its half-life is 4 hr. If M.J was administrated this drug every 8hr (TID), 1. Calculate the accumulation factor at steady state. 2. Calculate the average concentration for a dose of 200mg. 3. Calculate the maximum and minimum plasma concentrations (Cmax, Cmin) in the body at steady state if dose of 40mg. SET III: For a multiple IV bolus regimen in a one-compartmental model, under following conditions, a) Decrease clearance by two-fold b) Increase volume of distribution by two-fold c) Double each dose amount d) Change dosing interval from twice a day (BID) to once a day (QD) Discuss the change of the average steady-state concentration, the peak concentration, and the fluctuation scenarios Cavg,ssCmax_ssF a) CL 2 folds ↓ b) Vd ↑2 folds c) D 2 folds ↑ d)
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