Reanalysis for PK Reason: Gone with the Wind [Bioanalytics]

posted by Ohlbe – France, 2020-07-16 19:15 (278 d 21:00 ago) – Posting: # 21721
Views: 2,981

Dear Helmut,

» » » According to the current guidelines (EMA 2011, FDA 2018, ICH draft 2019) it is no more acceptable. IMHO, bad science.
» »
» » Agreed.
» Agreed on what? That is not acceptable or that it is bad science?

That it is bad science, of course ! To accept as a matter of principle data which are obviously incorrect, and to refuse as a matter of principle for these data to be corrected, is something I fail to understand.

I understand that assessors may be suspicious if there were some re-analyses for PK reasons. If the study is only borderline passing, they always have the possibility to perform (or ask for) a statistical analysis with the original data. Depending on the outcome, they may ask for an inspection.


Complete thread:

 Admin contact
21,419 posts in 4,475 threads, 1,510 registered users;
online 10 (0 registered, 10 guests [including 4 identified bots]).
Forum time: Wednesday 16:15 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