Two-stage designs versus European scaled average designs in bioequivalence studies for highly variable drugs: Which to choose?
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DOI: 10.1002/sim.7452
Abstract: The usual approach to determine bioequivalence for highly variable drugs is scaled average bioequivalence, which is based on expanding the limits as a function of the within-subject variability in the reference formulation. This requires separately… read more here.
Keywords: bioequivalence; highly variable; two stage; variable drugs ... See more keywords
Generative Neural Networks for Addressing the Bioequivalence of Highly Variable Drugs
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DOI: 10.3390/a18050266
Abstract: Bioequivalence assessment of highly variable drugs (HVDs) remains a significant challenge, as the application of scaled approaches requires replicate designs, complex statistical analyses, and varies between regulatory authorities (e.g., FDA and EMA). This study introduces… read more here.
Keywords: highly variable; generative neural; variable drugs; bioequivalence ... See more keywords