Truncated 72 hours [NCA / SHAM]

posted by M.tareq  – 2020-07-16 17:05 (223 d 11:28 ago) – Posting: # 21717
Views: 1,576

» 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.

There have been some publications: Model‐based analyses of bioequivalence and Link : 2 about using model-based approach to drive BE, though as you said it's not acceptable in BE "yet", do you think in the near future we will see model based BE studies approved by regulators?

Complete thread:

Activity
 Admin contact
21,355 posts in 4,458 threads, 1,493 registered users;
online 8 (0 registered, 8 guests [including 2 identified bots]).
Forum time: Thursday 03:33 CET (Europe/Vienna)

The rise of biometry in this 20th century,
like that of geometry in the 3rd century before Christ,
seems to mark out one of the great ages or critical periods
in the advance of the human understanding.    R.A. Fisher

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5