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...
Main Authors: | Joseph Kotsybar, Susan Hakeem, Lei Zhang, Wenlei Jiang |
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Format: | Article |
Language: | English |
Published: |
Wiley
2023-12-01
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Series: | Clinical and Translational Science |
Online Access: | https://doi.org/10.1111/cts.13670 |
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