Exposure Margin Calculation:
This is an example of how exposure margin calculated for dog 4 week (IV) study using body surface area (BSA) formula. Clinical information: Human Proposed “Start Dose”: 1.5 mg/day Dog to Human conversion factor = 1.8 HED = Human Equivalent Dose Dog 4 week (IV) study:
| Animal Dose —> | 0.25 mg/kg/day | 0.8 mg/kg/day | 2.5 mg/kg/day |
|
HED = Animal Dose / Conversion factor Dog to Human conversion factor 1.8 |
= 0.25/1.8 = 0.139 mg/kg/day |
=0.8/1.8 =0.44 mg/kg/day |
=2.5/1.8 =1.39 mg/kg/day |
|
mg/kg/day —> mg/day Human weight 60 kg |
=0.139*60 =8.33 mg/day |
=0.44*60 =26.67 mg/day |
=1.39*60 =83.33 mg/day |
|
Proposed Human Start Dose =1.5 mg/day |
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Exposure Margin = HED/Human dose |
=8.33/1.5 =5.6 |
26.67/1.5 =17.78 |
=83.33/1.5 =55.55 |
| Exposure Margin | 5.6 | 18 | 56 |
