Bioequivalence and Bioavailability Forum • Reference-Scaled Average Bioequivalence

Brus
★

Spain,
2023-06-06 14:18
(315 d 10:14 ago)

Posting: # 23578
Views: 1,350

Reference-Scaled Average Bioequivalence [RSABE / ABEL]

Dear all,

I have reviewed the RSABE design possibilities according new draft FDA guideline Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA and in accordance with FDA Draft Guidance on Progesterone; regarding RSABE. And it is set out as follow:

- Full replicate: 4-ways, 2-sequences: TRTR/RTRT
- Partial replicate: 3-ways, 3-sequences: TRR / RTR / RRT

But nothing is said about the option full-replicate 3-ways, 2-sequences: TRT / RTR, which does seem to be included in the guideline Statistical Approaches to Establishing Bioequivalence. Does this mean that this design can no longer be used?

Thank you so much

Best regards,

Edit: Guidances linked. [Helmut]

Helmut
★★★

Vienna, Austria,
2023-06-07 12:22
(314 d 12:10 ago)

@ Brus
Posting: # 23579
Views: 1,122

FDA: TRT|RTR instead of TRR|RTR|RRT?

Post reply

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]

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Helmut Schütz

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