FDA: TRT|RTR instead of TRR|RTR|RRT? [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2023-06-07 12:22 (373 d 04:17 ago) – Posting: # 23579
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Hi Brus,

❝ But nothing is said about the option full-replicate 3-ways, 2-sequences: TRT / RTR,……

Stupid enough. We may run into trouble if we have to assess the study in a partial replicate design for ABE because \(\small{s_\text{wR} < 0.294}\). See this article. At a webinar in March 2023 I tried to ask Donald Schuirmann.
The 👨‍✈️ steering moderating the »Panel Dis­cus­sions« decided to ignore my question… Instead, the only question related to SABE was “How is a Highly Variable Drug defined?”, which Donald explained at great length. Oh dear, what a waste of time!

❝ … which does seem to be included in the guideline Statistical Approaches to Establishing Bio­equi­valence.

Pragmatic: This one is the newest one. ;-)

❝ Does this mean that this design can no longer be used?

I don’t see any reason for not doing so. Why should we use an inferior method in lieu of a better one? If in doubt, initiate a controlled correspondence with the [image].

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