PK modeling in BE [NCA / SHAM]

posted by Helmut Homepage – Vienna, Austria, 2020-07-16 18:30 (278 d 21:40 ago) – Posting: # 21719
Views: 1,768

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 10th 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
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,419 posts in 4,475 threads, 1,510 registered users;
online 10 (0 registered, 10 guests [including 2 identified bots]).
Forum time: Wednesday 16:10 CEST (Europe/Vienna)

In the Middles Ages the lingua franca of science was Latin.
Nowadays the language of science is bad English.    Anonymous

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