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

posted by nobody - 2017-05-08 14:52  - Posting: # 17317
Views: 11,041

» » … 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

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I suppose it is tempting, if the only tool you have is a hammer,
to treat everything as if it were a nail.    Abraham Maslow

BEBAC Ing. Helmut Schütz