Bioequivalence and Bioavailability Forum • Calculation of AUC0-72

Calculation of AUC0-72 [NCA / SHAM]

posted by Helmut – Vienna, Austria, 2009-01-26 18:20 (6000 d 09:15 ago) – Posting: # 3126
Views: 35,481

Dear D. Labes,

❝ I am with you if the values in the last part of the concentration time course are <LOQ. But I think it's different with missing values (vial broken or so) especially in case of long half life drugs.

If a value is missing – or even came up as <LOQ in repeated analyses – and is included within values which are clearly (!) above LOQ I routinely substitute such a value by a (log)interpolated estimate. I have such a procedure since decades (oh, I’m getting old) in my protocols, and never got any problems.

❝ Because time points are spread occasionally with 24h in the last part, there may be a considerable portion of AUC missing.

This wouldn’t bother me as long as C_last ≥2–4 times t_max.

❝ ❝ I wouldn’t start trying to get an estimate of C₇₂.

❝

❝ Is this sentence then furthermore your opinion?

Yes.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Complete thread:

Calculation of AUC0-72 Sasi 2008-06-10 10:44
- Calculation of AUC0-72 Jaime_R 2008-06-10 12:18
  - Calculation of AUC0-72 Ohlbe 2008-06-10 17:28
    - Calculation of AUC0-72 Jaime_R 2008-06-10 18:45
      - Regulators truncated d_labes 2009-06-18 09:26
        
        Regulators truncated Ohlbe 2009-06-18 10:37
        Regulators truncated Helmut 2009-06-18 14:49
        
        Regulators truncated d_labes 2009-06-18 15:26
        
        Regulators truncated Helmut 2009-06-18 15:44
        
        Regulators truncated ElMaestro 2009-06-19 22:16
        
        Regulators truncated Helmut 2009-06-19 22:35
        
        Luke 23:34 ElMaestro 2009-06-18 14:50
    - Calculation of AUC0-72 d_labes 2008-09-05 15:00
      - Calculation of AUC0-72 Helmut 2009-01-26 16:24
        
        Calculation of AUC0-72 d_labes 2009-01-26 16:57
        
        Calculation of AUC0-72Helmut 2009-01-26 17:20
        
        The missing 72h d_labes 2009-01-27 11:48
        
        The missing 72h Ohlbe 2009-01-28 00:00
        
        sensitivity analyses ? martin 2009-01-28 08:26
        Regulators ways are inscrutable d_labes 2009-01-28 09:54
        
        Regulators ways are inscrutable (at least the French) Ohlbe 2009-01-28 10:16
        
        The missing 72h ElMaestro 2009-01-28 14:32
        
        Page 3848 of 221 d_labes 2009-01-28 14:51
        
        Partial AUC calculation Astea 2017-03-11 20:14
        
        Partial AUC calculation mittyri 2017-03-16 19:46
- Calculation of AUC0-72 PharmCat 2022-12-21 20:49