Parallel design & Reference-scaling [RSABE / ABEL]

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

Helmut Schütz

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