Bioequivalence and Bioavailability Forum • Truncated 72 hours

Truncated 72 hours [NCA / SHAM]

posted by M.tareq – 2020-07-16 19:05 (1607 d 00:07 ago) – Posting: # 21717
Views: 5,475

❝ 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 t_½ of 4 hours and the 10% poor metabolizers 16 hours. You end up with an overall (geometric mean) t_½ 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:

Truncated 72 hours mmw 2015-02-09 11:12 [NCA / SHAM]
- Truncated 72 hours Dr_Dan 2015-02-09 12:59
- Truncated 72 hours Helmut 2015-02-09 16:10
  - Truncated 72 hours nobody 2015-02-09 22:48
    - Truncated 72 hours mmw 2015-02-11 12:57
  - Truncated 72 hours stic-stats 2020-07-13 14:22
    - Truncated 72 hours Helmut 2020-07-13 17:07
      - Truncated 72 hours stic-stats 2020-07-15 06:17
  - Truncated 72 hours M.tareq 2020-07-16 01:36
    - Truncated 72 hours Helmut 2020-07-16 11:56
      - Truncated 72 hoursM.tareq 2020-07-16 17:05
        
        PK modeling in BE Helmut 2020-07-16 18:30
        
        PK modeling in BE mittyri 2020-07-19 00:24
        
        PK modeling in BE Helmut 2020-07-19 12:35