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

posted by Ohlbe – France, 2020-07-16 21:15 (1819 d 19:16 ago) – Posting: # 21721
Views: 11,137

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.

Regards
Ohlbe

Complete thread:

UA Flag
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,682 registered users;
45 visitors (0 registered, 45 guests [including 8 identified bots]).
Forum time: 16:31 CEST (Europe/Vienna)

To know that we know what we know,
and to know that we do not know what we do not know,
that is true knowledge.    Nicolaus Copernicus

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