Global harmonization of immediate‐release solid oral drug product bioequivalence recommendations and the impact on generic drug development

Abstract Immediate‐release (IR) solid oral drug products constitute a significant portion of approved drug products and products under development. Bioequivalence (BE) assessment for these oral products is important for establishing therapeutic equivalence for generic products to their respective co...

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Main Authors: Joseph Kotsybar (Author), Susan Hakeem (Author), Lei Zhang (Author), Wenlei Jiang (Author)
Format: Book
Published: Wiley, 2023-12-01T00:00:00Z.
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