Interaction Size From the Mechanistic Static Model (ICH M12)
Predicted exposure change from ICH M12's mechanistic static model, gut and liver, for inhibition and induction.
Open the tool → Runs in your browser. Data leaves only if you deliberately send a problem report from the interactive tool.
Example
- fm
- 0.9
- Ki
- 0.5
- Induction Emax
- 4
- Induction EC50
- 1
- Liver concentration [I]h
- 1
Result: Combined AUCR 1 is within 0.80 to 1.25, but inhibition alone gives 2.5 and induction alone 0.3571
The tool opens with these values already filled in. Replace them with your own.
What you enter
- fm
- Substrate Fg
- Ki (µM)
- kinact (per minute)
- KI (µM)
- Enzyme for liver kdeg
- Liver kdeg (per minute)
- Gut kdeg (per minute)
The other 16 fields
- Induction Emax
- Induction EC50 (µM)
- Induction scaling factor d
- Liver concentration [I]h (µM)
- Gut concentration [I]g (µM)
- Estimate concentrations from the dose
- fu,p
- Cmax total (µM)
- Inhibitor dose (mg)
- Molecular weight (g/mol)
- Blood-to-plasma ratio RB
- Fa
- Inhibitor Fg
- ka (per minute)
- Qh (L/h)
- Qen (L/h)
How this is calculated
Citation
ICH M12 Guideline, Drug Interaction Studies (Step 4, May 21, 2024), section 7.5.1 and Table 3: the mechanistic static model, the [I]h and [I]g estimates with their stated defaults, and the 0.80 to 1.25 band. Read the source ↗
A reference and educational tool. Not medical, legal, or financial advice, and not a substitute for clinician judgment.