Webinar: Re­cord­ing avail­able [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2023-04-01 12:38 (438 d 20:23 ago) – Posting: # 23520
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Hi Achievwin & all,

❝ Wishful thinking: I hope they give clear direction (kill once for all) - the annoying center/group effect portion for BE studies conducted in one country and in homogenous population.

❝ ❝ FDA is organizing a webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence

Yesterday the recording was posted. You need some stamina watching it. 🥱 😴
The presenters essentially read out what’s on their slides and didn’t provide any background information whatsoever. Since the slides were available for download before, I prepared comments/questions and tried to make them short and as concise as possible.Interestingly, none of my questions were selected by the moderator. After I posted the second, I received a message “Please post your question only once.” Heck, it was a different one. One which was selected:

How is a Highly Variable Drug defined and is this information available on and within the RLD labeling?

Oh dear, what a waste of time!

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
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