What's the current situation regarding chiral assays? [Bioanalytics]

posted by ElMaestro  – Denmark, 2017-12-16 13:31 (2295 d 01:18 ago) – Posting: # 18064
Views: 3,070

Hi all,

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

My impression is, given the EU guideline wording in 4.1.5 and the current practice that I have seen that regulators are not really enforcing the guideline the way it is written but occasionally they just happen to be.
I cannot see a pattern in the practice. If someone asks me when a chiral assay is truly necessary (guideline wording apart) then I will have to draw a blank.

Anyone out there able to describe how the guideline wording translates into assessor practice in plain words?

Many thanks and have a good day.

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
106 visitors (0 registered, 106 guests [including 10 identified bots]).
Forum time: 14:50 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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