The “backdoor” [Bioanalytics]

posted by Helmut Homepage – Vienna, Austria, 2017-12-16 13:23 (1701 d 12:10 ago) – Posting: # 18065
Views: 2,389

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 🖖 [image]
Helmut Schütz
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
22,301 posts in 4,667 threads, 1,585 registered users;
online 13 (0 registered, 13 guests [including 6 identified bots]).
Forum time: Sunday 02:33 CEST (Europe/Vienna)

No written law has ever been more binding than
unwritten custom supported by popular opinion.    Carrie Chapman Catt

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