Parallel design & Reference-scaling [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2018-09-07 15:27 (746 d 19:53 ago) – Posting: # 19250
Views: 1,958

Hi Sundar,

» Is it possible to design the reference scaled approach following parallel study (single period)?

By definition reference-scaling is applicable if the within-subject variability of the reference is >30%. CVwR is not accessible in a parallel design (not even CVw…).

» If yes, how to design the study, randomization and statistical procedures?

Tóthfalusi and Endrényi proposed a method for studies in a parallel design.1 However, in a follow-up paper2 they didn’t mention parallel designs any more. Given the troubles we already are facing with replicate designs (inflation of the Type I Error, convergence issues in the partial replicate) I guess the chance of a rather exotic approach to be accepted by any agency is practically zero.


  1. Tóthfalusi L, Endrényi L. An Exact Procedure for the Evaluation of Reference-Scaled Average Bioequivalence. AAPS J. 2016;18(2):476–89. doi:10.1208/s12248-016-9873-6. [image] PMC Free Full text.
  2. Tóthfalusi L, Endrényi L. Algorithms for evaluating reference scaled average bioequivalence: Power, bias, and consumer risk. Stat Med. 2017;36(27):4378–90. doi:10.1002/sim.7440.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,071 posts in 4,393 threads, 1,466 registered users;
online 4 (0 registered, 4 guests [including 1 identified bots]).
Forum time: Wednesday 11:20 CEST (Europe/Vienna)

The important thing in science is not so much to obtain new facts
as to discover new ways of thinking about them.    William Henry Bragg

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