Partial replicate design: reference(s)? [RSABE / ABEL]

posted by ElMaestro  – Belgium?, 2020-08-13 15:23 (109 d 16:18 ago) – Posting: # 21869
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(edited by ElMaestro on 2020-08-13 15:43)

Hi Hötzi,

it is very interesting. I looked at Chow&Liu's 2009 version of the holy scriptures and they also seem not to mention RTR/RRT/TRR.

I can easily imagine that some innovator had a presub meeting with FDA (about which not much is in the public domain) and then the idea caught on in a rather un-public way and later got the nod from EMA. It is speculation of course but such things would often happen at the initiative in the private sector behind the curtains.
I don't recall the details of dossiers I assessed, I am fairly sure that I (incompetently, of course) assessed BE trials based on RTR/RRT/TRR designs from 2005 and onwards, but I am not 100% sure. Had I not sniffed all that glue, memories of the past would likely have been less foggy.

It might also be that one of the consortia like PQRI could have looked into the matter and released a white paper. I have no idea, but what a mystery :-)
My money is on Walter Hauck, if you can get hold of him, he will tell you where it all came from.


Update: Kamal Midha referred to it as ABE3 in a presentation from 2006.
https://wayback.archive-it.org/7993/20170405065959/https://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4241s2_3_files/frame.htm

Is there an easy way to download that thing, by the way????

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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