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

posted by Helmut Homepage – Vienna, Austria, 2020-07-16 20:39 (924 d 17:42 ago) – Posting: # 21720
Views: 4,572

Dear Ohlbe,

❝ ❝ 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? Don’t feel pushed to answer. :-D

❝ Strangely enough, according to discussions I had with people involved in drafting the EMA guideline, it seems that it was the assessors who did not want to hear about PK repeats, not the inspectors…


That’s very strange indeed.

❝ … – though the latter are well known for their paranoia, and for good reasons.


Of course.

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