Parent only. Chiral assay? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-12-06 00:26 (680 d 21:53 ago) – Posting: # 20935
Views: 1,166

Hi ElMaestro & Elena777,

@Elena777: 1) according to the GL. Full stop.

» my recent experience in EU is that they tend to ask for the parent, and only the parent, if this can be measured (and if systemically acting blah blah).

@ElMaestro: Agree. Guideline =  cookbook  holy book nowadays.

» There is also some regulatory wobble regarding enantiomers. Sometimes they ask for a chiral assay,……

Really? Happened to me only once in 2010 though the other way ’round.

» … and sometimes they don't and their choice seems not to always follow the formal criteria criteria stated in the guideline. I haven't cracked the code yet, but Hötzi has a good story about it from the horse's mouth. :-D
» Hötzi, over to you...

Aye, capt’n!
Nothing to add to this one. In the meantime we have almost 70 APIs covered in product-specific guidances. In none a chiral assay is recommended.

[image]


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
21,729 posts in 4,543 threads, 1,543 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Saturday 23:19 CEST (Europe/Vienna)

If you want to converse with me,
define your terms.    Voltaire

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