Question
Your Company is testing the efficacy/toxicity of the new investigational pharmaceutical compound ABX. They administered ABX to a healthy volunteer (male, 31 year old, 80
Your Company is testing the efficacy/toxicity of the new investigational pharmaceutical compound ABX. They administered ABX to a healthy volunteer (male, 31 year old, 80 kg) as a single intravenous injection of 5 mg/kg. The following plasma concentrations were collected: Time (hours) Conc. (g/mL) 0.1 1.142 0.5 1.0627 1 0.9712 8 0.2755 16 0.0653 24 0.0155 48 0.0002 Calculate: a) Volume of distribution b) Elimination rate constant c) Elimination half-life d) Area under the curve e) Clearance f) The concentration at t=10 hours g) The amount in the body at t=10 hours h) The fraction of the dose left in the body at t=24 hours i) How many half-lives it takes to eliminate 90% of the dose? j) What is the duration of action for compound ABX in this subject given that the minimum effective concentration is 0.25 g/mL? Predict: a) The plasma concentration at t=0 following a dose of 10 mg/kg b) The plasma concentration at t=14 hours for the 10mg/kg dose c) The fraction of the dose left in the body at t=24 hours d) The duration of the effect for the 10mg/kg dose Preliminary studies in monkeys indicated the onset of severe side effects when the plasma concentration exceeds 10 g/mL. What is the maximum dose that can be administered in this subject?
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