Replicate vs. 2×2×2 (ethics?) [Regulatives / Guidelines]

posted by nobody – 2017-05-08 14:52  – Posting: # 17317
Views: 17,325

» » … and not as a result of outliers
»
» Nobody knows how to deal with this story. :-( Regulations  science. Not required by the FDA…

... sorry, no.

But this "it's safe because it has been shown to be safe in clinical practice over the last decades"-argumentation (question one above) never really went well in EU, I guess. At least you need to write a new, Chapter 2.5-like overview on the pk, pharmacology, safety to make the assessor sleep well next night after reading your application for a generic. On the other hand, assessors for originator's MAs have a much, much better sleep (better sleeping pills?), in my experience...


Edit: Please don’t shout! [Helmut]

Kindest regards, nobody

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,299 posts in 4,101 threads, 1,316 registered users;
online 15 (3 registered, 12 guests [including 7 identified bots]).

I have no opinion about ‘incurred samples’ –
an expression which has no easily understandable
meaning for me in the English language.    Nick Holford

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5