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Joseph Kotsybar

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Articles

Global Harmonization of Immediate‐Release Solid Oral Drug Product Bioequivalence Recommendations and the Impact on Generic Drug Development

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By Lei Zhang, Wenlei Jiang, Joseph Kotsybar, Susan Hakeem
| Wiley Online Library Verified
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 comparator products.
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