## Calculation of AUC0-72 [NCA / SHAM]

Dear D. Labes,

sorry for the late response – I was driven by discussions about the drafted European BE-Guideline.

» I would like to discuss this a bit further.

» How do you act in a truncated setting if the last sample is missing? Or if some subject has conc. <LOQ due to faster kinetics?

»

» Omit this subject from the analysis?

I have heard of CROs omitting subjects if AUC

I wouldn’t start trying to get an estimate of C

Edit (years later)

sorry for the late response – I was driven by discussions about the drafted European BE-Guideline.

» I would like to discuss this a bit further.

» How do you act in a truncated setting if the last sample is missing? Or if some subject has conc. <LOQ due to faster kinetics?

»

» Omit this subject from the analysis?

I have heard of CROs omitting subjects if AUC

_{72}was stated as the primary parameter and the sample at 72 h (or earlier) was ≤LOQ. In the strict sense I would consider this correct.**But:**with the current trend of moving from seening BE as a surrogate of clinical safety/efficacy to a measure of pharmaceutical performance*in vivo*I would go with Kamal Midha’s Mantra and accept AUCs where the absorption is completed (C_{last}≥2–4 times t_{max}). See Example 2 in this thread. If we truncate AUCs of subjects with C_{last}<72 (for*any*treatment) at the last time point where C>LOQ (for*all*treatments), it should be possible to get an unbiased estimate of the T/R-ratio.* Unfortunately this method is not available in commercial software (at least not in the current versions of WinNonlin, Kinetica, EquivTest/PK).I wouldn’t start trying to get an estimate of C

_{72}.Edit (years later)

- Fisher D, Kramer W, Burmeister Getz E.
*Evaluation of a Scenario in Which Estimates of Bioequivalence Are Biased and a Proposed Solution: t*J Clin Pharm. 2016;56(7):794–800. doi:10.1002/jcph.663. free resource._{last}(Common).

—

Cheers,

Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮

Science Quotes

Cheers,

Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮

Science Quotes

### 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

- Regulators truncated ElMaestro 2009-06-19 22:16

- Regulators truncated Helmut 2009-06-18 15:44

- Regulators truncated d_labes 2009-06-18 15:26
- Luke 23:34 ElMaestro 2009-06-18 14:50

- Regulators truncated d_labes 2009-06-18 09:26
- Calculation of AUC0-72 d_labes 2008-09-05 15:00
- Calculation of AUC0-72Helmut 2009-01-26 16:24
- Calculation of AUC0-72 d_labes 2009-01-26 16:57
- Calculation of AUC0-72 Helmut 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

- The missing 72h Ohlbe 2009-01-28 00:00

- The missing 72h d_labes 2009-01-27 11:48

- Calculation of AUC0-72 Helmut 2009-01-26 17:20

- Calculation of AUC0-72 d_labes 2009-01-26 16:57

- Calculation of AUC0-72Helmut 2009-01-26 16:24

- Calculation of AUC0-72 Jaime_R 2008-06-10 18:45

- Calculation of AUC0-72 Ohlbe 2008-06-10 17:28

- Calculation of AUC0-72 Jaime_R 2008-06-10 12:18