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

posted by Helmut Homepage – Vienna, Austria, 2020-07-16 18:39 (187 d 19:57 ago) – Posting: # 21720
Views: 2,520

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.

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
21,308 posts in 4,444 threads, 1,489 registered users;
online 10 (0 registered, 10 guests [including 4 identified bots]).
Forum time: Wednesday 13:36 CET (Europe/Vienna)

Power: That which is wielded by the priesthood of
clinical trials, the statisticians, and a stick which they use
to beta their colleagues.    Stephen Senn

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