Reference-Scaled Average Bioequivalence [RSABE / ABEL]

posted by Brus – Spain, 2023-06-06 14:18 (704 d 20:47 ago) – Posting: # 23578
Views: 2,771

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Bioequivalence Studies With Pharmacokinetic End­points for Drugs Submitted Under an ANDA and in accordance with FDA Draft Guidance on Progesterone; regarding RSABE.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]

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,669 registered users;
119 visitors (0 registered, 119 guests [including 5 identified bots]).
Forum time: 11:05 CEST (Europe/Vienna)

Lack of clarity is always a sign of dishonesty.    Celia Green

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