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

posted by Helmut Homepage – Vienna, Austria, 2020-07-16 18:39 (378 d 16:01 ago) – Posting: # 21720
Views: 3,315

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
21,592 posts in 4,514 threads, 1,532 registered users;
online 8 (0 registered, 8 guests [including 4 identified bots]).
Forum time: Friday 10:40 CEST (Europe/Vienna)

It is a capital mistake to theorise before one has data.    Arthur Conan Doyle

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