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A biowaiver is acceptable for BCS Class I drugs if the excipients that may affect absorption are qualitatively the same (i.e., identical chemistry, grade, and characterization) and quantitatively similar (i.e., within 10% of the weight of excipient in the reference product and a cumulative difference within 10%)

For example, one supplement may be 42% elemental magnesium while another might be 10%

doi: 10.1016/j.exer.2022.109278 272 LinLTChenJTTaiMCChenYHChenCLPaoSIet al

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