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Although there is data indicating that migrations with moderate changes produce equivalent instrument versions, hence do not require quantitative equivalence studies, additional work is necessary to establish this.
Equivalence studies set out to define how similar treatments might be.
Equivalence studies are common in clinical trials, where unlike superiority studies, the goal is to show whether a new drug therapy is as effective as a standard one.
For actual application of equivalence tests and advance planning of equivalence studies, both SAS and R computer codes are available as supplementary files to implement the calculations of critical values, p-values, power levels, and sample sizes.
Hence, compositional equivalence studies uniquely required for GM crops may no longer be justified on the basis of scientific uncertainty".
In fact, this contradictory possibility was already highlighted in the same review by EFSA (p. S60), when substantial equivalence studies and other analyses were performed: "animal feeding trials with rodents adds little if anything, and is not recommended".
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The active controlled equivalence study could offer a potential alternative design.
Background: With the various twin-bag systems available on the market, we decided to conduct a therapeutic equivalence study comparing ANDY-Disc (Fresenius Medical Care, Bad Homburg, Germany) with UltraBag (Baxter, Deerfield, IL) in patients on continuous ambulatory peritoneal dialysis (CAPD) therapy.
This paper presents a new sample size formula for Cochran's test that uses additional information on stratum-specific success rates and requires fewer subjects for an equivalence study.
In the absence of documented evidence of measurement equivalence, it is strongly recommended that a quantitative equivalence study be conducted before mixing modes in a trial to ensure that sufficient equivalence can be demonstrated to have confidence in pooling PRO data collected by the different modes.
In particular, we examine the equivalence between J-am and Heston-am as an extension of the equivalence studied by Jerbi (Quantitative Finance, 15:2015–2015, 2015).
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