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RegisterTruncated 72 hours [NCA / SHAM]
posted by Helmut 
– Vienna, Austria, 2020-07-16 13:56 (1765 d 09:01 ago) – Posting: # 21711
Views: 6,422
Hi Mahmoud,
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.
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).
❝ 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).
—
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Ing. Helmut Schütz