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RegisterTruncated AUC or 3 Half-Lives? EMA BE Design for Inhaled Product [Regulatives / Guidelines]
Hi A. Shtaiwi!
The concentration at elimination phase can be below LLOQ, but still you can calculate AUC0-72 hr. Considering a half life of about 24 hr as a worst case, still you should be able to have measurable concentration at 72 hr. If feasible- it will be good to further lower down the LLOQ which can give more data for AUC/Kel consideration.
It will be good to predefine truncated AUC.
Divyen
❝ If we plan a truncated design (for example AUC₀–72h), many subjects may have BLQ samples before 72 hours, leading to missing AUC₀–72h data.
The concentration at elimination phase can be below LLOQ, but still you can calculate AUC0-72 hr. Considering a half life of about 24 hr as a worst case, still you should be able to have measurable concentration at 72 hr. If feasible- it will be good to further lower down the LLOQ which can give more data for AUC/Kel consideration.
❝ Or should we predefine a truncated AUC window (e.g., AUC₀–72h) and avoid relying on AUC₀–t and AUC₀–∞?
It will be good to predefine truncated AUC.
Divyen
Complete thread:
- Truncated AUC or 3 Half-Lives? EMA BE Design for Inhaled Product A.Shtaiwi 2026-02-02 08:32
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- Truncated AUC or 3 Half-Lives? EMA BE Design for Inhaled Productdshah 2026-02-18 07:04
Ing. Helmut Schütz