Enlighten me please [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2017-09-07 00:52 (2395 d 15:27 ago) – Posting: # 17788
Views: 4,626

Hi Jag,

❝ I don't get it. The message has always been (or almost always been) to show BE for parent if it can be accurately quantified since it is the one that gets absorbed. Someone was :party: when the document was written?


I agree this is unusual. I don't know if they were partying too hard when they wrote this guideline but I can easily imagine there is a compromise of sorts involved here; perhaps someone from another FDA office (DBRUP?) wasn't convinced or was inexperienced with BE and used intuition instead of reason? Sometimes these guidelines, even though they are issued by OGD, involve a ton of inter-division compromises. I am sure that unless you find a really good reason buried in the material on the originator available via FOI the reason is going to be very hard to identify. :-|

We all have to be sheep in this situation, I guess.:-):-)

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
124 visitors (0 registered, 124 guests [including 7 identified bots]).
Forum time: 15:19 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