Study Parameters

Governing Equations

Allometric Scaling (Body Weight):
  CL_animal = CL_human · (BW_animal / BW_human)^0.75
  Dose_HED = Dose_animal · (BW_animal / BW_human)^0.25

NOAEL: No Observed Adverse Effect Level
  Highest dose with no statistically significant adverse effects

MTD: Maximum Tolerated Dose
  Highest dose that does not cause unacceptable toxicity
  Typically defined as ≤ 10% body weight loss or grade 2 toxicity

MRSD (Maximum Recommended Starting Dose):
  MRSD = HED / Safety Factor (typically 10)

Safety Margin:
  SM = NOAEL / HED
  SM ≥ 10 for first-in-human acceptable

Dose-Response (Probit):
  P(toxicity) = Φ(a + b·log(dose))
  where Φ = cumulative normal distribution