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

posted by Ohlbe – France, 2020-07-16 21:15 (866 d 22:42 ago) – Posting: # 21721
Views: 4,547

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

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