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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:

  1. Volume of distribution
  2. Elimination rate constant
  3. Elimination half-life
  4. Area under the curve
  5. Clearance
  6. The concentration at t=10 hours
  7. The amount in the body at t=10 hours
  8. The fraction of the dose left in the body at t=24 hours
  9. 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:

  1. The plasma concentration at t=0 following a dose of 10 mg/kg
  2. The plasma concentration at t=14 hours for the 10mg/kg dose
  3. The fraction of the dose left in the body at t=24 hours
  4. 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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