The “backdoor” [Bioanalytics]

posted by Helmut Homepage – Vienna, Austria, 2017-12-16 13:23 (1379 d 15:07 ago) – Posting: # 18065
Views: 2,290

Hi ElMaestro,

» what is the current regulatory sentiment towards the need for chiral assays?

Duno. Agree with your other statements. See also this post. At a conference in 2014 another regulator told me that this paragraph is a kind of “loophole”:

“If we don’t like [sic!] the study and find no other reason to reject it, we can use the backdoor…”

Note also that all product-specific guidances published so far don’t recommend a chiral assay.

Dif-tor heh smusma 🖖
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

 Admin contact
21,699 posts in 4,537 threads, 1,542 registered users;
online 4 (0 registered, 4 guests [including 4 identified bots]).
Forum time: Sunday 05:31 CEST (Europe/Vienna)

A central lesson of science is that to understand complex issues
(or even simple ones), we must try to free our minds of dogma and
to guarantee the freedom to publish, to contradict, and to experiment.
Arguments from authority are unacceptable.    Carl Sagan

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