Vienna, Austria,
2020-06-12 12:12

Posting: # 21531
Views: 169

 Bracketing Approach [Power / Sample Size]

Dear all,

two participants of the recent survey commented that the “Bracketing Approach” (e.g., non-superiority of Cmax, non-inferiority of Cmin)* and testing for equivalence of AUC is not available in the software they are using most (without naming it).

In PowerTOST it is implemented (see its vignette for examples). Since the CV of AUC is generally lower than the ones of Cmax/Cmin it will not drive the sample size.

  • EMA, CHMP. Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms. London; 20 November 2014. EMA/CHMP/EWP/280/96 Rev1.
    “5.1.1. Waiving of therapeutic studies
    Cmax,ss for the new MR formulation is below or equivalent to the Cmax,ss for the approved formulation and Cmin,ss for the MR formulation is above or equivalent to the Cmin,ss of the approved formulation.”

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Helmut Schütz

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