Brus
★    

Spain,
2023-06-06 14:18
(178 d 08:31 ago)

Posting: # 23578
Views: 996
 

 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Bioequivalence Studies With Pharmacokinetic End­points for Drugs Submitted Under an ANDA and in accordance with FDA Draft Guidance on Progesterone; regarding RSABE.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
★★★
avatar
Homepage
Vienna, Austria,
2023-06-07 12:22
(177 d 10:27 ago)

@ Brus
Posting: # 23579
Views: 804
 

 FDA: TRT|RTR instead of TRR|RTR|RRT?

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 recent webinar I tried to ask Donald Schuirmann. Was ignored…

❝ … 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.

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

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
UA Flag
Activity
 Admin contact
22,811 posts in 4,783 threads, 1,643 registered users;
27 visitors (0 registered, 27 guests [including 7 identified bots]).
Forum time: 21:50 CET (Europe/Vienna)

Nothing shocks me. I’m a scientist.    Harrison Ford (as Indiana Jones)

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5