Refuse-to-Receive Standards [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2017-02-27 17:25 (2585 d 16:24 ago) – Posting: # 17115
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Hi David,

❝ […] would it be acceptable to use different designs for each study? Even when the variability in the fed study was preivously found to be higher in pilot studies, for example?


A replicate design is advantageous if aiming at reference-scaling. However, the FDA is special. If RSABE is not stated in the respective product-specific guidance1 (as an alternative to ABE) I would not risk it2 without controlled correspondence first – otherwise one may fall into this trap.

❝ […] from my experience fed studies generally have higher variability than fast studies even when no food effect is expected.


Indeed.


  1. Most in draft state and published before April 2010 (when RSABE was for the first time mentioned by the FDA).
    Omeprazole, Pantoprazole: No. Lansoprazole: Yes (only fasting :confused:).
  2. Of course, in statistical terms any replicate design – even if aimed only at ABE – is better than a simple crossover.

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