Truncated 72 hours [NCA / SHAM]

posted by Helmut Homepage – Vienna, Austria, 2020-07-16 09:56 (29 d 16:19 ago) – Posting: # 21711
Views: 926

Hi Mahmoud,

» Is it possible to use a model-based approach to estimate the overall/typical value of Ke or CL and use that for prediction of such points ?

Since PK modeling is not acceptable in BE, no. Furthermore, an average value might be misleading. Imagine the drug is subjected to polymorphic metabolism. The 90% extensive metabolizers have an average t½ of 4 hours and the 10% poor metabolizers 16 hours. You end up with an overall (geometric mean) t½ 4.59 hours. Now you could think about basing the decision to which group the subject belongs (i.e., instead of the average, use 4 or 16 hours) on the AUC. Spice the data with high between subject variability and you are at a loss.

» Or is it simpler to just perform a log-linear regression on averaged/all terminal points (3xTmax) and use that estimate to account for such deviations as defined in protocol.

That’s exactly what I do (and performed in Phoenix/WinNonlin when you specify a partial AUC0–72 with missings and/or deviations from the scheduled 72 hours sampling).

Dif-tor heh smusma 🖖
Helmut Schütz

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