Relative Infant Dose Through Breast Milk (FDA Draft Guidance)
Relative infant dose and estimated infant dosage through breast milk.
Open the calculator → Runs in your browser. Data leaves only if you deliberately send a problem report from the interactive tool.
Example
- Average milk concentration
- 100
- Concentration unit
- ng/mL
- Maternal dose
- 100 mg/day
- Maternal weight
- 60 kg
Result: Relative infant dose 0.9% at 150 mL/kg a day of milk (1.2% at 200 mL/kg a day); estimated infant dosage 0.015 mg/kg a day.
The tool opens with these values already filled in. Replace them with your own.
What you enter
- Average milk concentration (or use the ratio and plasma concentration)
- Milk-plasma ratio
- Average maternal plasma concentration
- Concentration unit
- Maternal dose
- Maternal weight
- Approved infant dose (optional)
How this is calculated
Citation
FDA. Clinical Lactation Studies: Considerations for Study Design. Draft guidance for industry, May 2019: estimated daily infant dosage, relative infant dose, and milk intakes of 150 and 200 mL/kg/day. Read the source ↗
A reference and educational tool. Not medical, legal, or financial advice, and not a substitute for clinician judgment.