Active metabolites: to measure or not to measure [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2019-12-05 23:22 (295 d 17:48 ago) – Posting: # 20934
Views: 939

Hello Elena777,

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).
I did not see a dossier recently where they asked additionally into the metabolite.
So, as regards parent versus metabolite they seem in my experience to follow guidelines to the word, but with one exception: You can have a great meeting with 16 questions, all being answered in no time, and you are ready to leave the agency with final handshakes and big smiles, when someone whispers: "Hey, what about back-conversion?" Then all bets are off, especially if you are not 120% sure you have firm control over it. You can be asked to measure everything and do all what that it implies in terms of acquisition of weird reference standards and setting up assays. :crying:


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

I could be wrong, but...

Best regards,
ElMaestro

R's base package has 274 reserved words and operators, along with 1761 functions. I can use 18 of them (about 14 of them properly). I believe this makes me the Donald Trump of programming.

Complete thread:

Activity
 Admin contact
21,076 posts in 4,394 threads, 1,469 registered users;
online 4 (1 registered, 3 guests [including 2 identified bots]).
Forum time: Saturday 18:10 CEST (Europe/Vienna)

For every fact
there is an infinity of hypotheses.    Robert M. Pirsig

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