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Local SM calculation based on local concentration at the injection site and Virtual space volume.
| Dose (mg) | Concentration* (mg/mL) | Virtual Space Volume** (mL) | Virtual Space Conc. (mg/mL) | Margins | ||
|---|---|---|---|---|---|---|
| By Local Conc. | By Virtual Space Conc. | |||||
| Human proposed study | A | C | E | A/E | ||
| Toxicology study NOAEL |
B | D | F | B/F | D/C | (B/F)/(A/E) |
Concentration of the drug product administered
Note that references should be provided to support the virtual space volumes for specific species
