Critical Remarks on Reference-Scaled Average Bioequivalence

Purpose: More than a decade ago the option to assess highly variable drugs / drug products by reference-scaled average bioequivalence was introduced in regulatory practice. Recommended approaches differ between jurisdictions and may lead to different conclusions even for the same data set. According...

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Bibliographic Details
Main Authors: Helmut Schütz (Author), Detlew Labes (Author), Martin J. Wolfsegger (Author)
Format: Book
Published: Frontiers Media S.A., 2022-09-01T00:00:00Z.
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3rd Floor Main Library

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Call Number: A1234.567
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