The missing 72h [NCA / SHAM]

posted by ElMaestro  – Denmark, 2009-01-28 15:32 (5172 d 23:03 ago) – Posting: # 3155
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❝ 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.

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