Truncated 72 hours [NCA / SHAM]

posted by M.tareq  – 2020-07-16 15:05 (275 d 08:32 ago) – Posting: # 21717
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» 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?

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