The missing 72h [NCA / SHAM]
❝ 1. Option: Exclude subject
❝ 2. Option: Use AUC(0-48)
❝ 3. Option: Extrapolate to 72h (C(calc.)=5.69 using log-lin regression with * points) and calculate then AUC (result=595.85).
Hi,
I'd go for option 3 (after all we are used to extrapolations when it comes to AUCinf and nobody has a problem with that. If you can extrapolate something to inf then why not to 72 hrs. as well?!).
Excluding a subject is a possibility if something went wrong (vial broken, a UFO landed and the chromatograph melted, etc).
The CHMP has been working a lot on aspects of missing values etc, and they have come up with all sorts of strange concepts that have very little relevance for this situation.
Finally, depending on the combo of RMS and CMSs it might not make a difference at all what you choose. Of course, if you advertise in a very clear manner that something is fishy in the dataset then you might be able to force the assessor to look into it, but why not just leave it as it is and mention it on page 3848 and hope for the best.
Martin: 'Sensitivity analyses' (them being a lot of things) are probly a good idea. But it has absolutely no focus for PK assessors at the moment. But in a centralised procedure with survival curves the CHMP will sing with loud and clear voice "oh yeah, gimme gimme gimme sensitivity analyses"
EM.
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 AUC0-72 Helmut 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 72hElMaestro 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 AUC0-72 Helmut 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 PharmCat 2022-12-21 20:49
- Calculation of AUC0-72 Jaime_R 2008-06-10 12:18