Bioequivalence and Bioavailability Forum 11:11 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Parallel design & Reference-scaling [RSABE / ABEL]

posted by Helmut Homepage - Vienna, Austria, 2018-09-07 15:27  - Posting: # 19250
Views: 604

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] free resource.
  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.

Cheers,
Helmut Schütz
[image]

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

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,187 posts in 4,084 threads, 1,308 registered users;
online 16 (0 registered, 16 guests [including 12 identified bots]).

In these days, a man who says a thing cannot be done
is quite apt to be interrupted by some idiot doing it.    Elbert Green Hubbard

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed