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Scaled average bioequivalence methods for highly variable drugs: Leveling-off soft limits and the EMA's 2010 guideline (some ways to improve its type I error control)
Muñoz, Joel; Ocaña, Jordi; Suárez, Rolando; Millapán, Carolina (2024)The regulatory EMA's reference scaled average bioequivalence (RSABE) approach for highly variable drugs suffers from some type I error control problems at the neighborhood of the 30% coefficient of variation (CV), where ...