Truncated 72 hours [NCA / SHAM]

posted by M.tareq  – 2020-07-16 17:05 (104 d 16:43 ago) – Posting: # 21717
Views: 1,252

» 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
21,179 posts in 4,414 threads, 1,477 registered users;
online 10 (1 registered, 9 guests [including 4 identified bots]).
Forum time: Thursday 08:48 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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