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Registerlong half-life AUC0-t or AUC0-72 [NCA / SHAM]
Hi everyone,
When calculating AUC0–∞, I know some regulatory agencies use extrapolation while others use the actual value. For a long half-life product truncated at 72 hours, should I use AUC0–t or AUC0–72 for bioequivalence assessment?
I think these two value may differ when 72h has a LLOQ.
Thank you!
Edit: Category changed; see also this post #1. [Helmut]
When calculating AUC0–∞, I know some regulatory agencies use extrapolation while others use the actual value. For a long half-life product truncated at 72 hours, should I use AUC0–t or AUC0–72 for bioequivalence assessment?
I think these two value may differ when 72h has a LLOQ.Thank you!
Edit: Category changed; see also this post #1. [Helmut]
Complete thread:
- long half-life AUC0-t or AUC0-72Darborn 2025-10-14 05:34 [NCA / SHAM]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- IR with t½ ≥ 24 h Helmut 2025-10-14 10:30
- IR with t½ ≥ 24 h Darborn 2025-10-16 06:05
- long half life product? Helmut 2025-10-16 08:13
- long half life product? Darborn 2025-10-17 05:16
- long half life product? Helmut 2025-10-16 08:13
- IR with t½ ≥ 24 h Darborn 2025-10-16 06:05
- long half-life AUC0-t or AUC0-72 ElMaestro 2025-10-15 17:41
- long half-life AUC0-t or AUC0-72 Darborn 2025-10-16 06:00
- IR with t½ ≥ 24 h Helmut 2025-10-14 10:30
Ing. Helmut Schütz