Bioequivalence and Bioavailability Forum

PK modeling in BE [NCA / SHAM]

posted by Helmut  – Vienna, Austria, 2020-07-16 16:30 (29 d 09:07 ago) – Posting: # 21719
Views: 886

Hi Mahmoud,

» There have been some publications: […] 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?

I’m not very optimistic, esp. when dealing with missing data or – even worse – sparse sampling. Mats Karlson (quoted in your second reference) is extremely clever and France Mentré has my deepest respect when it comes to PopPK. However, last year at the 10^th American Conference on Pharmacometrics (20–23 October, Orlando) she gave a presentation “Evaluation of Model Based BioEquivalence (MBBE) statistical approaches for sparse designs PK studies” with a whoopy mean (!) Type I Error of 7.6%. 

I hope that we can clarify things later this year.

—
Dif-tor heh smusma 🖖
Helmut Schütz


The quality of responses received is directly proportional to the quality of the question asked. 🚮
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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 hours M.tareq 2020-07-16 17:05
          • PK modeling in BEHelmut 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