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:
- Volume of distribution
- Elimination rate constant
- Elimination half-life
- Area under the curve
- Clearance
- The concentration at t=10 hours
- The amount in the body at t=10 hours
- The fraction of the dose left in the body at t=24 hours
- 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:
- The plasma concentration at t=0 following a dose of 10 mg/kg
- The plasma concentration at t=14 hours for the 10mg/kg dose
- The fraction of the dose left in the body at t=24 hours
- 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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