The FDA’s fourth BE approach! Yada Yada Yada [Regulatives / Guidelines]

posted by jag009  – NJ, 2015-09-23 22:29 (3433 d 13:00 ago) – Posting: # 15461
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Hi Helmut,

❝ As if pulling a rabbit out of the hat. László Endrényi regularly goes ballistic on this issue. He showed already twenty years ago (in the context of IBE) that this limit is arbitrary and the “method” flawed.


I was in one local BA/BE meeting last week in NJ. One of the ex-FDA presenter (consultant) made a short "blasting" speech on the Sub*formulation interaction test on Concerta... I wonder when my old prof Laszlo will start his own campaign....

John

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