Evaluating the bioequivalence of two pitavastatin calcium formulations based on IVIVC modeling and clinical study

• Main Authors: Jiaying Wang (Author), Jinliang Chen (Author), Lu Wang (Author), Dandan Yang (Author), Rong Shao (Author), Honggang Lou (Author), Zourong Ruan (Author), Bo Jiang (Author)
• Format: Bog
• Udgivet: Wiley, 2023-01-01T00:00:00Z.
• Fag: article
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Abstract In vitro‐in vivo correlation (IVIVC) allows prediction of the in vivo performance of a pharmaceutical product based on its in vitro drug release profiles and can be used to reduce the number of bioequivalence (BE) studies during product development, and facilitate certain regulatory decisio...